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Careers 2017-11-16T09:31:26+00:00

Imagine playing an exciting key role in a digital health company that is changing the way mental health care is delivered through objective, data-driven screening, diagnosis, monitoring and management.

The success of that mission is dependent on people who are passionate visionaries, focused on a brighter and better tomorrow.

When you walk through our doors, you will meet dedicated and hardworking individuals, collaborating together in order to reduce the impact of psychological disorders and aid in proper diagnosis.

As a global leader, we have opportunities for motivated individuals at our locations in Australia and throughout the USA.

Are you ready to join the Medibio Revolution?

Current Opportunities

Australia

Lead Clinical Research Associate, Melbourne, 2017-09

Background

The World Health Organization recognizes psychiatric disorders as the largest clinical problem in the world in terms of Disability Adjusted Life-Years with an estimated 350M people suffering from major depressive disorder (MDD) alone.  Medibio understands that fewer than 10% of individuals receive optimal treatment upon initial assessment, resulting in reduced quality and quantity of life.  We want to make it our mission to improve that.

The current state of the art diagnostic tools for clinicians are limited to questionnaires and subjective analysis of lifestyle and emotional response. To help us to continue to provide objective, biomarker-based analytical tools to clinicians at the point of patient contact, we need passionate visionaries who seek to reduce the impact of psychological disorders and aid in proper diagnosis.  If you want a career that will challenge and engage you and one where the reward of seeing people get the support and help they need, then Medibio may be the place for you.

Medibio has compiled the world’s largest dataset of physiologic recordings combined with associated psychiatric assessment. The company is now seeking a top notch Lead Clinical Research Associate for our Melbourne office.  This Position will join a team made up of fascinating people in the unofficial sporting capital of Australia.  We are looking for people who want to have fun, understand what it means to have a start-up mentality, are passionate about the work Medibio is doing, own their work while successfully collaborating in functional and cross-functional teams.

Job Summary

The Lead CRA will support Global Clinical Operations and lead the Australia Clinical Research Associate (CRA) group, being responsible for the performance of trial sites in Australasia region (determined by project), in accordance with Good Clinical Practice (GCP), ICH guidelines and relevant regulations. The key focus for this position will be site qualification, initiation, monitoring and closeout. Reporting to the Director of Clinical Operations, the Lead CRA will contribute to monitoring plans and other trial site documents and tools with ongoing reporting responsibilities for progress of recruitment and overall trial site including document management.  The Lead CRA will also act as primary liaison between CRAs and project management, with mentoring, oversight and training responsibilities. The Lead CRA will also be expected to have a close collaboration with data management and medical monitor to support query management and quality reporting.

Essential Functions

  • Responsible for providing oversight of the entire site management process for the life cycle of the trial sites, with the development and maintenance of trial documents, logs and tracking of site performance metrics.
  • Responsible for ensuring site qualification (pre-study), initiation, monitoring and study closeout visits are conducted in accordance with US and AUS federal regulations, Good Clinical Practices, ICH Guidelines, and Standard Operating Procedures and business processes.
  • Responsible for monitoring activities of assigned sites and as primary liaison for all clinical monitoring issues, escalating as appropriate to Study Manager and / or Director in accordance with relevant study plans and Standard Operating Procedures and business processes.
  • Accountable for the coordination of the CRA team, ensuring appropriate CRA visit scheduling per protocol and monitoring plan with reporting on monitoring activity to include status report, co-monitoring (qualification) visits and trip report metrics.
  • Responsible for collaborating with the CRA to develop any Corrective and Prevention Action plan (CAPA) relating to non-compliance at site. Accountable for ensuring that the CAPA is delivered and issues escalated to the Study Manager as required by the clinical project plan and Standard Operating Procedures and business processes.
  • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits, including file review according to the clinical project plan.
  • Reviewing and entering all protocol deviations in collaboration with the CRAs and escalating as required.
  • Developing and maintaining a country recruitment / retention strategy in collaboration with the Study Manager. Identifying potential risks to the enrollment targets based on feasibility and recruitment updates in collaboration with the Study Manager.
  • Responsible for attending, participating and presenting at Investigator meetings as needed.
  • Assisting with project specific training, oversight and mentoring of CRAs and in-house staff.
  • Supporting the Data Manager, Study Manager and Medical Monitor in communicating and resolving issues and obtaining follow-up information.
  • Responsibility to hire, train, motivate and manage a growing number of CRAs based in Australia
  • Travel in Australia will be required and may be extensive at times.
  • Other duties as assigned

Minimum Requirements

  • Minimum of 5-10 years of direct CRA experience within a sponsor or CRO organization, with 3+ years Management experience.
  • Minimum Bachelor’s degree in a scientific discipline. Advanced degrees and hands-on medical device experience strongly desired.
  • Must be prepared to be a motivator and leader of people.
  • Demonstrable computer skills (MS Office, MS Project, PowerPoint).
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
  • Thorough knowledge of ICH, GCP, CFR and AUS Directives.
  • Monitoring experience in Medical Device is preferred.
  • Experience of working within a small and / or “start-up organization would be advantageous.
  • experienced in managing a varied and complex workload.
  • Experienced in building relationships with current and potential investigators
  • High energy “hands on” individual who understands clinical development

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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USA

Senior User Experience Designer, Savage MN, 2017-14

Job Summary

The Senior User Experience Designer will be responsible for translating ideas and concepts into a first-generation mobile and web based product for mental health patients and professionals.  The designer will be a UX generalist in a start-up environment, responsible for end-to-end user experience—from research and testing through interface development and product information architecture. Deliverables will be both consumer and clinician applications designed to be not just engaging and delightful, but essential to management of mental health conditions.

Essential Functions

  • Map user journeys and flows for comprehensive use cases and user personas, working closely with the business and technology teams
  • Rapidly prototype low- and high-fidelity wireframes for customer testing and team design sessions and support implementation with the development teams
  • Turn data and insights into engaging experiences for end users
  • Harden and perfect the product experience and design through careful and deliberate review and design
  • Drive usability studies, A/B testing, other design evaluation techniques and create action plans based on results
  • Create a design language and style guide to drive the overall brand, style and personality of the product
  • Practice human-centered design daily
  • Other duties as assigned

Minimum Requirements

  • User Experience Designer would have a B.A., B.F.A. or B.S. in Graphic Design or related field and five or more years of experience in UX design, ideally for a consumer-direct product.
  • Minimum 7 years’ experience contributing to the product design of clinician- and patient-facing products in the healthcare or medical fields
  • Deep understanding of human computer interaction, how humans think and behave, cultural differences among humans and how technology can be used for forming new habits.
  • Desire to work in a fast-paced environment, not afraid to fail, learn and evolve on a daily basis
  • Ability to communicate, present, negotiate and defend design choices, as well as synthesize team feedback into the best possible solution
  • Proven track record in delivering delightful and easy-to-use products and services based on user needs, business, and research, able to provide case studies
  • A strong portfolio of work, especially in web and mobile application design
  • You must live, love and breathe design—you have favorite apps for their interactions, typography, visual design
  • Strong visual design experience preferred, experience running product design workshops
  • Ability to determine the best approach – desktop, mobile, hybrid – depending on the system requirements
  • Hands on experience with workflow, wireframing and schematic creation tools like Sketch, Illustrator, InVision
  • Development experience would be a plus, but not required
  • Ability to travel up to 10% of time

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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Senior Product Manager, Savage MN, 2017-13

Job Summary

The Sr. Product Manager actively communicates with customers and physicians to garner feedback and generate product development ideas and pro-actively shares these insights to drive critical product release schedules for Medibio’s mental health products.  Driving, overseeing and coordinating product definition, schedules and cross-functional integration teams, the Sr. Product Manager will ensure the timely delivery of targeted products and implement process improvement efforts where needed. Engaging stakeholders such as engineering, marketing and other functional leaders and project managers across the organization is key to deliver on time, in budget and in demand products.

Essential Functions

  • Gathers, evaluates and has a solid understanding of customer use cases, manages product feature backlog, continually prioritize, reassess and track progress of project deliverables; redirect as needed to ensure on-time releases
  • Develops product vision and roadmap plan aligned with business strategy and communicates across all critical stakeholders
  • Lead program execution across the product development organization, working effectively with Engineering, Marketing and other functional leaders supporting vertical integration efforts
  • Partner with SBU (strategic business unit) managers to develop product strategies that include market positioning, product pricing, product costing, gross margin analysis and distribution pathways to ensure profit margin targets are achieved
  • Implement best practices and product/project tools to aid in the communication throughout the organization, reducing risk, and driving accountability
  • Analyze and search for opportunities to streamline product development and processes for effectiveness and continuous improvement
  • Coordinate and lead product and cross-functional meetings, holding team-members accountable for commitments timelines and deliverables.
  • Work with assigned functional leads to coordinate and facilitate key program level hand-offs
  • Develops multiple hypothesis-driven product evaluation strategies, including AB testing for interactive products, and assesses the expected efficacy of each.
  • Own program level dependencies in order to accurately define program level risks and partner with stake holders to develop mitigation plans and/or contingencies if needed
  • Manage technical and cross-functional timelines to ensure projects are on track and on budget to deliver against the market requirements
  • Drives key end-to-end lifecycle components, from planning to release, has a thorough understanding of the company’s SDLC processes, including agile processes
  • Proactively seek out and be aware of upgrades and new product introductions in order to anticipate and resolve performance and related issues, working cross functionally with business and supply partners
  • Ensure voice of physician and customers experience is carried out from concept to development

 Minimum Requirements

  • The ideal candidate will have exceptional background in product and project management preferably in a fast paced/start up
  • Passionate about our industry and the creation of products that delight and are endeared by our customers and physicians
  • Strong product and project skills & capabilities, technical & business acumen with effective communication skills to drive accountability through all phases of development cycle
  • 5+ years’ experience with leading cross functional teams as a technical program or project manager is ideal
  • Experience with SAAS platforms and mobile applications, specifically with medical industry is required with a focus on Mental Health highly desired
  • Previous experience working directly with Engineering in order to facilitate effective communication and project management
  • Ability to think both strategically and tactically in a fast-paced environment
  • Ability to articulate physician and customer needs and coordinate efforts through an agile multi-site development to market environment
  • Proven track record of summarizing customer and physician needs and use cases, bringing forth ideas and executing projects on time and on budget
  • Exceptional interpersonal, influencing, and communication (written and verbal) skills
  • Experience working in a regulated industry, dealing with data privacy concerns
  • Excellent organizational and critical thinking skills
  • Ability to prioritize and multi-task
  • Experience with product roadmap and application lifecycle management tools
  • Skilled in the Microsoft office suite, with strong knowledge of Microsoft Project
  • Bachelor’s degree required with MBA and PMP preferred
  • Ability to travel 20% of the time

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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Vice President Data Science, Minnesota, 2017-06B

Job Summary

As the VP of Data Science (DS), champion a data-driven culture and drive long-term business value creation through the development of best-in-class data science capabilities.  The VP of DS is responsible for the strategic planning and daily oversight of a world-wide date science team.  As a key center of excellence for Medibio, the VP of DS will lead the development and validation of core algorithms, based on various feature sets, that will be commercialized as objective decision support tools for the objective identification, stratification and management of broad spectrum of mental health conditions.  As a player/coach, the VP of DS will work to build and retain a team of skilled and passionate employees.  Working along side the Technology team, Product Management team and other teams within the organization, the VP of DS will drive the objectives and plans and implement solutions by utilizing tactical execution of the company’s product roadmap.

 Essential Functions

  • Act as a subject matter expert and thought leader in the industry within the space of Machine Learning and Artificial Intelligence; designing and overseeing projects associated with Advanced Analytics.
  • Provide oversight as to the Data Science road map based on business priorities and company strategy.
  • Leverage physiological features (biomarkers) along with relevant Psychosocial inputs (including clinical history, demographics, etc.) to characterize and monitor mental state.
  • Lead algorithm research and development and manage a team of data scientists and analysts with expertise in hypothesis formation, data preparation, feature engineering, model development, performance validation and integration into production systems. In addition, they will interpret physiological signals (biomarkers) associated with heart rate, sleep and actigraphy.
  • Support collaborations with leading academic and industry partners and drive the development of intellectual property.
  • Lead and contribute to the success of the Data Science team members in the discovery of novel biomarkers for use in metal health related products.
  • Provide training and leadership in thought generation, analysis, code and mentorship.
  • Support product roadmap initiatives with validated algorithms and models.
  • Responsible for code and documentation appropriate for regulatory filing.
  • Attract, hire, mentor and retain needed talent to build a world-class Data Science team at appropriate levels to maximize business impact and successfully execute the strategic vision.
  • Partner with Data Engineering leadership to design a world-class machine learning infrastructure environment.
  • Create new analyses, models, and/or tools that deliver insights that enable the business partners to further their objectives.
  • Manage a pipeline of projects/products and their on-time delivery, communicating effectively and proactively addressing and problem-solving roadblocks.
  • Oversee machine learning and artificial intelligence techniques to design and implement feedback mechanisms to identify and monitor mental health states from which to develop targeted sales pipelines.
  • Develop and implement Best Practices in Analytics Operations to support the strategic organizational goals and successfully meet FDA and other clinical and federal guidelines.

Minimum Requirements

  • Advanced degree in technical/quantitative discipline (CS, Engineering, Math, Statistics)
  • 15+ years of demonstrated leadership in Data Science and scientific R&D
  • 7+ years working directly with physiologic signals. Leading algorithm efforts for a wearable company a plus.
  • Thorough understanding of physiological signals and sensing systems
  • Expertise in machine learning, signal processing, and statistical analysis
  • Exceptional people manager, mentor, and leader
  • Significant experience in building and leading highly successful Data Science teams
  • Strong track record of leveraging data analytic methods within the Technology sector and experience with large data-sets to create data-driven insights
  • Expert command of Machine Learning, statistical modeling, state-of-the-art tools, and engineering best practices.
  • Expert knowledge of data mining techniques and tools with SAS, Python, R, etc. is required. Expert proficiency interrogating relational data bases with SQL and with using, managing workload with distributed computing tools (Map/Reduce, Hadoop, Hive, etc.)
  • Excellent project management skills, with a proven track record of on-time and within-budget delivery. Exceptional ability to manage priorities across multiple stake holders.
  • Must be willing to travel up to 25%

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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Senior Manager Medical Affairs, Minnesota, 2017-12

Summary

The Sr. Manager Medical Affairs (Sr. MMA) is a key opinion leader in developing and disseminating clinical and scientific evidence supporting Medibio’s technologies.  The Sr. MMA will partner with internal cross-functional team-members (clinical, marketing, R&D) to solicit and incorporate scientific content to collaboratively build the Medibio story around’s it product and service offerings.

Essential Functions

  • Write, amend and proof all CSRs (Clinical Study Reports), SPCs (Summary of Product Characteristics), PILs (Patient Information Leaflets) and label information.
  • SME on Medibio’s products and services providing KOLs on content development for regulated and non-regulated programs.
  • Develop and maintain strong collaborative relationships with cross functional teams to collectively reinforce and align the appropriate clinical and commercial message.
  • Identify, develop and maintain critical partnerships with strategically targeted KOLs focused on Medibio’s mental health goals and objectives.
  • Solicit and incorporate feedback on content that will be utilized to build the Medibio story.
  • Coordinates with and strategically utilizes information resources to understand evidence as well as gaps and creates robust strategies/plans to address them.
  • Seek out and capture opportunities that endorse Medibio’s mission and vision, collaborating with cross functional teams to capture opportunities for various program venues (Wellness programs, etc).
  • Develop scientific speaker resource materials that can be leveraged by physician speakers.
  • Serve as scientific liaison between KOLs and internal teams.
  • Influence program agendas and support content development.
  • Represent clinical in support of customer engagement efforts.
  • Attend scientific conferences and programs in relevant therapeutic areas to maintain current knowledge.
  • Overnight travel (up to 25%) to scientific conferences and other meetings within and outside the U.S.
  • Is the internal and external contact for medical affairs projects
  • Responsible for development of Medibio’s publication plan(s)

Minimum Requirements

  • Bachelor’s degree required in Life Science area; MD or MS / PhD preferred in a related field
  • 5+ years of medical education/clinical/pre-clinical/product development/marketing/field clinical experience
  • Must have the ability to manage simultaneous priorities, changing deadlines, and resource management
  • Knowledge of Global Medical Affairs (strongly preferred)
  • Proven ability to engage, influence and build effective relationships
  • Strong interpersonal skills to enable cross function success
  • Proven experience in the medical industry (clinical, scientific communications, medical affairs, medical education, product management, product development, R&D, medical sales, or field clinical engineer) and in an FDA-regulated and non-regulated environment preferred
  • Excellent written and verbal communication
  • Ability to build rapport with key physicians and medical leadership
  • Must be highly proficient in the use of Microsoft Office Suite, especially PowerPoint
  • Strong leadership skills and experience of managing priority brands
  • Strong network of external experts in mental health preferred

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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Executive Administrative Assistant, Minnesota, 2017-11

Job Summary

The Executive Administrative Assistant (EAA) will provide support to the CEO as well as other leaders on an as needed basis.  The ability to anticipate, plan ahead, create contingency plans and communicate effectively is key to success in this faced paced-high growth organization.  With minimal supervision, the EAA will perform administrative duties including but not limited to board prep, creating and preparing PowerPoint presentations, schedules, materials and make worldwide travel arrangements and accommodations.  A high level of discretion and judgment must be used on a daily-basis.  As a publicly traded company, the EAA must handle confidential information professionally and appropriately.

Essential Functions

  • Prioritizes and successfully manages a high volume of work, balancing priorities to meet deadlines.
  • Oversees Administrative Assistant and provides daily work direction; acts as a back up to the assistant.
  • Key point of contact for the Board of Directors; Coordinates board meetings and activities as well as creates and compiles board prep materials.  Travels to board meetings as needed and manages daily activities to ensure all sessions are well coordinated and executed.
  • Consistent communication (texting, emailing, calls) with CEO related to business needs, travel arrangements and other activities in order to stay abreast and up to date on action items
  • Plans and manages the CEO’s calendar.
  • Schedules meetings and works within international time zones for travel arrangements.  Allows for sufficient travel times (both domestic and international) in order to ensure on-time starts.  Fully prepares agendas for participants including contact information, call in numbers, needed attachments, etc.
    • Creates detailed travel itineraries including air, car, hotel confirmation numbers, seat assignments, ticket numbers, airline record locator etc.
    • Anticipates and identifies potential issues or obstacles to executive plans/itineraries and advises and provides options/solutions
    • Follows up on any needs and changes throughout travel schedule and stays abreast of weather and any other issues that could impact travel plans
  • Partners with local, international teams for meetings or events as needed, ensuring information is received, meetings are accepted and accommodations are made.
  • Independently manages assigned projects, anticipates and plans ahead, prepares reports and other needed documents.
  • Manages the CEO’s financial administrative tasks related to corporate card, invoices and expense reports.
  • Effectively uses tools such as MS Word, PowerPoint, Excel, WebEx, videoconference and teleconference.
  • Responsible for formatting consistency and accuracy on time-sensitive, high-profile and confidential documents.
  • Leads/Works on special projects or assignments as needed.
  • Interacts with all levels of leadership

Schedule Expectations

  • 8:30am-5:30pm with flexibility to work beyond normal business hours when needed
  • Ability to work during non-business hours and be on call for emergencies

 Minimum Requirements

  • Associates degree (Bachelor’s Preferred) or equivalent combination of education and experience.
  • Seven (7+) plus years executive assistant experience or Administrative Assistant supporting a number of management team members
  • Experience working for a fast paced, constantly changing global company (start up experience preferred)
  • Ability to respond to shifting priorities and anticipate needs
  • Ability to work independently with little to no direction at times
  • Owns one’s work
  • Schedule flexibility
  • Strong knowledge and experience with Excel, PowerPoint, Word, and Outlook as well as virtual meeting tools (WebEx, Videoconferencing, etc.)
  • Strong verbal and written communication skills and executive presence
  • Excellent organizational skills, with a high attention to quality and detail
  • Ability to learn and adapt quickly
  • Travel Requirement: Up to 10%

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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Senior Data Scientist, Minnesota, 2017-01

Background

The World Health Organization recognizes psychiatric disorders as the largest clinical problem in the world in terms of Disability Adjusted Life-Years with an estimated 350M people suffering from major depressive disorder (MDD) alone.  Medibio understands that fewer than 10% of individuals receive optimal treatment upon initial assessment, resulting in reduced quality and quantity of life.  We want to make it our mission to improve that.

The current state of the art diagnostic tools for clinicians are limited to questionnaires and subjective analysis of lifestyle and emotional response. To help us to continue to provide objective, biomarker-based analytical tools to clinicians at the point of patient contact, we need passionate visionaries who seek to reduce the impact of psychological disorders and aid in proper diagnosis.  If you want a career that will challenge and engage you and one where the reward of seeing people get the support and help they need, then Medibio may be the place for you.

Medibio has compiled the world’s largest dataset of physiologic recordings combined with associated psychiatric assessment. The company is now seeking a top notch Senior Data Scientist for our Melbourne office.  This position will join a world-wide team made up of fascinating people in order to help us establish a presence in the land of 10,000 lakes.  We are looking for people who want to have fun, understand what it means to have a start-up mentality, are passionate about the work Medibio is doing, own their work while successfully collaborating in functional and cross-functional teams.

Job Summary

The Sr. Data Scientist will assist in the sensing, discovery, and the development of biomarkers related to classification of mental health disorders. The role will entail working with clinical and ambulatory sensed data related to physiologic signals and behavior patterns.

Essential Functions

  • Collaborate with a team of doctors, engineers, and fellow data scientists around product goals and novel sensing modalities.
  • Research and develop methods for extracting parameters associated with human physiology.
  • Develop validated models associated with neurophysiological disorders.
  • Document and communicate results to the team in preparation for regulatory filing.

 Minimum Requirements

  • Passionate for developing products to serve patients and make lives better
  • Entrepreneurial, independent and collaborative with previous experience working in a fast-paced start-up.
  • Drives towards a positive outcome as the work you will do will directly impact the standard of care worldwide
  • A degree in Biomedical engineering, Statistics, Mathematics, Computer Science or other scientific fields (or equivalent experience). PhD preferred, but equivalent experience considered
  • 7+ years of experience developing models and insights from physiologic time-series data
  • Experience working with ECG (or other cardiac signals), EEG, and/or clinical PSG data a huge plus.
  • Proficiency with Python (daily user) and associated tools including pandas, sklearn and visualization packages. Coding (GitHub) references welcome
  • Deep knowledge and experience in signal processing, feature engineering, machine learning and statistical validation
  • Ability to innovate features and models beyond basic routines to meet performance objectives
  • Excellent written and verbal scientific communication and time management skills
  • Sensor (ideally physiological) experience – Understanding the common errors, and means (physics) of sensing to troubleshoot issues in data cleaning
  • Experience with subjective (noisy) labels – If you have worked with interpreting and mapping noisy labels, that would be fantastic!
  • Experience with experimental design and working with academic collaborators
  • Familiarity with health and medical regulatory processes

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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Director of Quality and Regulatory Affairs, Minnesota, 2017-05

Background

The World Health Organization recognizes psychiatric disorders as the largest clinical problem in the world in terms of Disability Adjusted Life-Years with an estimated 350M people suffering from major depressive disorder (MDD) alone.  Medibio understands that fewer than 10% of individuals receive optimal treatment upon initial assessment, resulting in reduced quality and quantity of life.  We want to make it our mission to improve that.

The current state of the art diagnostic tools for clinicians are limited to questionnaires and subjective analysis of lifestyle and emotional response. To help us to continue to provide objective, biomarker-based analytical tools to clinicians at the point of patient contact, we need passionate visionaries who seek to reduce the impact of psychological disorders and aid in proper diagnosis.  If you want a career that will challenge and engage you and one where the reward of seeing people get the support and help they need, then Medibio may be the place for you.

Medibio has compiled the world’s largest dataset of physiologic recordings combined with associated psychiatric assessment. The company is now seeking a top notch team member for our Savage, Minnesota office.  This position will join a world-wide team made up of fascinating people in order to help us build a world class organization.  We are looking for people who want to have fun, understand what it means to have a start-up mentality, are passionate about the work Medibio is doing, own their work while successfully collaborating in functional and cross-functional teams.

Job Summary

Responsible for overall management and direction of Medibio’s Quality Systems and Regulatory Affairs (QARA) to ensure successful achievement of business objectives and government compliance. The Director of QARA will be the primary contact for all interactions with the FDA and other regulatory bodies to ensure global strategies, submissions and objectives are met.   The Director of QARA will build a Quality and Regulatory team to manage current and emerging requirements and direct implementation activities to ensure compliance both here and abroad.  Successfully partnering with team-members in order to drive initiatives that ensure an effective Quality Management System is designed to meet appropriate company, government, and international standards/regulations for efficacy, safety, quality and compliance is key.  Develops metrics to track and measure compliance, with ultimate results demonstrated through successful audits by external client, federal authority and accreditation entities in both the USA and abroad.

Essential Functions

  • Management Representative: Responsibility and authority to ensure that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the quality management system and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization.
  • Hire, develop and lead a high performing regulatory and Quality team to ensure commitments, deadlines and compliance standards are met.
  • Create transparent processes and procedures and successfully partners with other functions to ensure regulatory and accreditation standards are met.
  • Participates in management meetings and provides guidance on regulatory and quality strategy to meet company objectives, establishing and implementing short- and long-range strategic business goals and activities to achieve these goals.
  • Prepares annual Quality and Regulatory department budgets in coordination with Finance department.
  • The primary contact during regulatory inspections.
  • Manages escalated customer issues and drives continuous improvement activities.
  • Identify and address gaps related to all aspects of product quality and compliance (e.g., product, quality systems, people), including opportunities for continuous ongoing innovation and improvements.
  • Effectively incorporates regulatory requirements into Standard Operating Procedures (SOPs) and ensure that these standards are successfully communicated and adhered to throughout the organization.
  • Define operational needs surrounding scalability and develop project plans to ensure ongoing compliance needs are met.
  • Assure the absence of significant quality issues and regulatory compliance actions by global government agencies through the design and governance of robust, efficient and consistent Quality Systems, internal and external audit programs, and inspection readiness programs.
  • Assure all supplier quality systems are consistent with worldwide quality and regulatory requirements.
  • Plans, coordinates, and executes regulatory submissions as appropriate.
  • Reviews all labeling for compliance with regulations and ensures that claims are substantiated and sustained.
  • Maintains current knowledge base on existing and emerging regulations, standards, and guidance documents.
  • Ensures organizational compliance with US and international regulations and requirements pertaining to regulatory submissions.
  • Responsible for planning and executing meetings with or related to global regulatory authorities (e.g., Notified Body, FDA and Advisory Panel meetings) as appropriate.
  • Other duties as assigned.

Minimum Requirements

  • BA/BS technical field or scientific discipline (biology, engineering, physical science, etc.)
  • Seven (7+) Years of experience:
    • In FDA regulated quality management
    • In direct US regulatory medical device submission experience preparing IDE and PMA submissions
    • Developing, interpreting or applying standards, guidelines and special controls
  • Three (3+) years of
    • Management experience in an FDA regulated environment
    • Experience with international submission preparation experience
  • Strong working knowledge and application of FDA regulations and requirements with the ability to integrate into projects.
  • Demonstrated strong interpersonal, communication, negotiation and project management skills
  • Strong oral and written skills to effectively communicate technical information and keep executive management informed
  • Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, and Complaints Handling
  • Technical aptitude and background in medical devices preferred.
  • Global experience in Regulatory and Quality requirements, audits, submissions, etc.
  • Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, MDD, GMP, GLP, GCP, HIPAA.
  • Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
  • Excellent written and oral communication and organizational, project management skills.
  • Strong US PMA supplement and reporting experience
  • Regulatory experience must include strategy development, submission authoring and publication
  • Significant advertising/promotion review experience
  • Working knowledge and experience with adverse event reporting; especially US MDR and EU vigilance reporting decision, preparation, and submission experience
  • Demonstrated effectiveness in managing and participating in regulatory body audits and inspections
  • Strong quality systems knowledge, particularly requirements of US Quality System Regulation and ISO 13485
  • Significant experience in review and interpretation of international standards
  • Self-motivated with outstanding prioritization skills
  • Demonstrated strong interpersonal, communication, negotiation and project management skills
  • Regulatory Affairs Certification by Regulatory Affairs Professional Society is highly desirable

We are an Equal Employment Opportunity Employer.  It is our policy to provide equal employment opportunities to all qualified persons without regard to race,  age, color, sex, sexual orientation, religion, national origin, disability, veteran status or marital status or any other proscribed category set forth in state or federal regulations.

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