Regulatory Affairs Senior Specialist
Posted on 3/28/2023
INACTIVE
Freenome

501-1,000 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.
AI & Machine Learning
Data & Analytics

Company Stage

Series D

Total Funding

$1.1B

Founded

2014

Headquarters

South San Francisco, California

Growth & Insights
Headcount

6 month growth

4%

1 year growth

13%

2 year growth

44%
Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • 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
Responsibilities
  • 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