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Full-Time

Regulatory Affairs Senior Specialist

Posted on 3/28/2023

Freenome

Freenome

501-1,000 employees

Develops blood tests for early cancer detection

AI & Machine Learning
Data & Analytics

Compensation Overview

$102k - $155k

Senior

San Bruno, CA, USA

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

Freenome is dedicated to advancing cancer detection through its multiomics platform, which integrates advanced machine learning techniques to analyze patterns in circulating biomarkers. This company is notable for its emphasis on early-stage colorectal cancer and advanced adenomas detection, positioning itself at the forefront of medical innovation in oncology. The collaborative and forward-thinking work environment, coupled with a mission-driven approach, makes it an appealing place for professionals looking to impact public health significantly.

Company Stage

Series D

Total Funding

$1.1B

Headquarters

South San Francisco, California

Founded

2014

Growth & Insights
Headcount

6 month growth

-3%

1 year growth

0%

2 year growth

23%

Benefits

Competitive market-based salaries

Annual bonus opportunities

Relocation packages

Medical, dental, & vision coverage

401k

Wellness programs

Equity

PTO

INACTIVE