Regulatory Affairs Senior Specialist
Posted on 3/28/2023
San Bruno, CA, USA
Experience Level
  • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science
  • Must have a minimum of 4-6 years of IVD Regulatory Affairs experience
  • This experience must include either 510(k), De Novo, PMA, PMA supplement submissions. Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
  • Knowledge of and experience in application of regulatory requirements
  • Regulatory review of promotional marketing materials, press releases, labeling, etc
  • Demonstrate understanding of development and regulatory path for IVD medical devices
  • High energy level; positive attitude; works well under pressure, strong communicator
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
  • Able to work autonomously in a matrix-managed organization
  • Ability to provide solutions based on knowledge of regulation and industry experience
  • Willingness to travel (~5-10%)
  • Comfortable with ambiguity and change
  • Responsible for supporting planned regulatory submissions
  • Participate in core teams and provide regulatory support
  • Document regulatory strategies for product submissions
  • Facilitate and prepare U.S. regulatory Pre Submission documents for multiomic platform
  • Participate in FDA pre submission meetings
  • Collaborate and support U.S. regulatory submissions (PMA, PMA supplement, and 510(k))
  • Perform regulatory assessment of new and changed products
  • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc
  • Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures

201-500 employees

Blood test cancer detection biotech company
Company Overview
Freenome's mission is to empower everyone to prevent, detect, and treat disease by developing high-quality diagnostic tests. The developing next-generation blood tests powered by their multiomics platform to discover the body’s earliest warning signs of cancer, and develop accessible tests to detect cancer in its earliest, most treatable stages.
  • Competitive market-based salaries
  • Annual bonus opportunities
  • Relocation packages
  • Medical, dental, & vision coverage
  • 401k
  • Wellness programs
  • Equity
  • PTO
Company Core Values
  • Empathy
  • Integrity
  • Trust
  • Strive for greatness
  • Servant leadership