Associate Director, Regulatory Affairs (CDx)

The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, developing regulatory strategy, and contributing to the regulatory approval process for Foundation Medicine products.

Requirements

• Manage premarket submissions for regulatory approval of in vitro companion diagnostic medical devices in the US market.
• Develop regulatory strategy with oversight for complex projects.
• Represent Foundation Medicine in interactions with external partners for companion diagnostic development or support for partner drug filings.
• Manage and mentor junior members of the Regulatory Affairs Team.
• Represent Regulatory Affairs department at cross-functional internal project meetings.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan