INACTIVE
Full-Time
Regulatory Affairs Manager
Blood test cancer detection biotech company
Data & Analytics
AI & Machine Learning
Compensation Overview
$127,500 - $195,000
Mid, Senior
San Bruno, CA, USA
Requirements
- 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
Responsibilities
- 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
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.
Company Stage
Series D
Total Funding
$1.1B
Headquarters
South San Francisco, California
Founded
2014
Growth & Insights
Headcount
6 month growth
↑ 5%1 year growth
↑ 14%2 year growth
↑ 44%Benefits
Competitive market-based salaries
Annual bonus opportunities
Relocation packages
Medical, dental, & vision coverage
401k
Wellness programs
Equity
PTO
INACTIVE