Posted on Apr 6, 2021 by Foundation Medicine, Inc.
The Vice President, Regulatory leads, manages, and implements regulatory strategy for FMI. The incumbent directs program efforts relative to pre-market submission and post launch compliance, companion diagnostic partnering with pharmaceutical companies, FDA interactions, regulatory policy and ex-US regulatory strategy. Using creative and strategic thinking, this role influences regulatory policy both within FMI as well externally.
Broaden the regulatory knowledge within the FMI leadership team, the organization, and strategic partners.
Ensure that FMI's quality system is effective and compliant with applicable regulations and follows the latest thinking throughout the industry.
Develop innovative strategies for rapid introduction of new discoveries in genetics and personalized medicine compliant with regulatory requirements.
Collaborate with leadership of all external regulatory and quality governing bodies to derive creative solutions on present service offerings through successful negotiations with the regulatory body.
Effectively manage regulatory aspects of diagnostic partner(s) to ensure quality programs are effective in providing results that meet or exceed the needs of the customers and regulatory agencies.
Maintain an up-to-date knowledge of regulatory procedures pertaining to FMI and provide analysis and evaluation at set intervals and as needed to ensure compliance and attainment of strategy.
Identify path to bring FMI products to regulatory approval and to bring products to market with optimum cost effectiveness and compliance.
Provide complete and timely submissions of regulatory documents to authorities.
Manage applicable internal training programs.
Provide regulatory guidance and strategy pertaining all stages of product development.
Oversee analysis of regulatory trends and activities in formation of regulatory strategy.
Provide mentoring to other members of the Regulatory team.
Domestic and international travel, approximately 10%.
Other duties as assigned.
One of the two following education and experience combinations:
Bachelor's Degree + 10+ years of progressively responsible experience in the device, pharmaceutical/biologics regulatory, or related scientific industry.
Advanced Degree (eg, Masters, JD, Ph.D.) in Science, Health Policy, Regulatory Affairs, Engineering or Law and 8+ years of progressively responsible experience in the device, pharmaceutical/biologics regulatory, or related scientific industry.
4+ years in a Regulatory affairs role.
Ph.D. in a life science, engineering or chemistry discipline.
12+ years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization.
6+ years working in a regulatory affairs department working on FDA regulatory submissions (PMAs, sPMAs, IDEs, SRDs, 510(k)s).
Experience engaging in direct negotiations with the FDA in resolving issues with submissions.
Experience preparing and submitting successful original PMAs.
An understanding of the multiple routes to clearance or approval of a diagnostic product.
Outstanding presentation and communication skills.
Strong history of achievement demonstrated by leadership activities, publications, presentations, or other activities.
Collaboration skills and the ability to effectively communicate (written and oral) with internal and external team members on project activities.
Experience and understanding of ex-US regulatory registrations and approvals.
Superior communication skills with a demonstrated ability to navigate a complex organization and generate buy-in for ideas and recommendations.
Understanding of HIPAA and the importance of patient data privacy.
Commitment to reflect FMI's values: passion, patients, innovation and collaboration.