Regulatory Affairs Manager

Why join Freenome?

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease.

To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

To fight the war on cancer, Freenome has raised more than $1.1B from leading investors including a16z, GV (formerly Google Ventures), T. Rowe Price, BainCapital, Perceptive Advisors, RA Capital Management, Roche, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures.

Are you ready for the fight? A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrive in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. Freenomers are determined, patient-centric,  and outcomes-driven. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. We are dedicated to advancing healthcare, one breakthrough at a time.

About this opportunity:

Freenome is seeking an experienced Regulatory Affairs professional to join the exciting area of Multiomic diagnostic products. Main area of focus is early cancer screening diagnostics. As a Manager of Regulatory Affair you will provide strategic and tactical support to In-Vitro Diagnostic core teams. You will also collaborate in regulatory strategies, FDA pre-submission package development, FDA meetings, and pre-approval submissions. The role reports to the Director of Regulatory Affairs.

What you’ll do:

• 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.

Must haves:

• 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.

Benefits and additional information:

The US target range of our base salary for new hires is $127,500 - $195,000 . You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits dependent on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ https://careers.freenome.com/ for additional company information.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

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