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Director of Regulatory Affairs

Biofidelity
Published
June 21, 2024
Location
Telecommute
Category
Other  
Job Type
Work Setting
Remote / Home-based

Description

Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate.

Job Summary
Biofidelity is looking for a dynamic, efficient and results-oriented Director of Regulatory Affairs to lead the planning, development and execution of our global regulatory affairs strategy for our first oncology diagnostic product and create fit for purpose regulatory function within the company. This position reports to the Chief Medical Officer and is remote based.
Key responsibilities
  • Design, develop and deliver global regulatory affairs strategy for both US (FDA) and EU to gain product approvals and bring products to market with optimum compliance and reimbursement opportunities.
  • Drive, develop and implement the US and international regulatory strategies and filings for our diagnostic products.
  • Represent Biofidelity before regulatory authorities.
  • Provide hands-on execution, oversight and strategic leadership of all regulatory submissions to ensure complete and timely submissions to authorities.
  • Maintain an up-to-date knowledge of global regulatory policies and procedures, and interpret trends that directly affect business decisions.
  • Provide expert regulatory advice, interpretation and guidance throughout all stages of product development.
  • Broaden the knowledge of regulatory aspects within R&D, clinical and commercial teams to help identify the optimal path to bring products to market.
  • Work closely with Quality Management to ensure Biofidelity’s quality system is efficient and compliant with regulatory requirements.
  • Support corporate compliance review for externally facing communications, working closely with medical affairs, marketing and corporate communication activities, including review of publications as required.
  • Coordinate, prepare and execute the successful delivery of high quality, timely regulatory submissions (EUAs, Pre-Sub, 510(k), and De Novo submissions) necessary to achieve regulatory approvals in the US.
  • Coordinate and prepare technical files / STEDs for submission to European Notified Bodies for timely CE marking of new and next generation products, with appropriate cross-functional input.
  • Establish and be recognized as a Regulatory Affairs SME by cross-functional teams.  Support as required, cross-functional initiatives, including but not limited to, controlled document content (policies, procedures, IFUs, QRGs), R&D validation and verification protocols and reports.
Knowledge, Skills, And Abilities
  • Proven hands-on execution and strategic leadership capabilities of building global Regulatory infrastructure and building teams.
  • Business acumen.
  • Experience with diagnostic development, oncology and hematology clinical biomarker development, and Next Generation Sequencing platforms.
  • Good understanding of the multiple routes to approval of a diagnostic product, including Companion Diagnostics.
  • Solid knowledge of overall compliance, including Quality Assurance, manufacturing, supporting software  and Quality Management Systems.
  • Excellent verbal and written communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, leaders, and senior management and external agencies.
  • Excellent cross-functional leadership  and project management leadership and organizational skills, with strong attention to detail.
  • Strategic thinker with ability to focus, execute and deliver on specific tactical needs and operational sides of the role as we build the team.
  • Cross-cultural awareness, ability to thrive in a small, dynamic and rapidly growing company environment.
  • Willingness to travel as required.
Requisite Education and Experience/Minimum Qualifications
  •  M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired.
  • RAC accreditation strongly preferred.
  • 5+ years of leadership experience in regulatory affairs function working on FDA regulatory submissions (must include oncology products).
  • Experience and previous submission of US (PMA) and ex-US (IVD and CDx) regulatory diagnostics submissions and approvals strongly preferred.
  • Demonstrated leadership in engaging in direct negotiations with regulatory bodies in resolving issues with submissions.
Apply
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