Regulatory Affairs Manager
Posted on 3/28/2023
San Bruno, CA, USA
Experience Level
  • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science
  • Masters Degree or RAPS Certificate preferred
  • Must have a minimum of 5-8 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
  • Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
  • Experience in the balance and application of regulatory requirements
  • Direct and positive experience in communicating with Regulatory Authorities and functional departments
  • Regulatory review of promotional marketing materials, press releases, labeling, etc
  • Demonstrate understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices
  • Capacity to communicate regulations to technical functions within the company
  • High energy level; positive attitude; works well under stress, Strong communicator and leader
  • 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 (~10-15%)
  • Comfortable with ambiguity and change
  • Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements
  • The delivery of regulatory guidance to project teams are key activities toward assisting the Company in achieving its business goals
  • Participate in the core team and provide active and ongoing regulatory guidance to project teams
  • 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 prepare 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
  • Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team's knowledge of working in a regulated environment
  • 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