Sr. Manager, Regulatory Affairs

The Sr. Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global standards. The devices in scope include physical devices, software in medical device (SiMD) and software as a medical device (SaMD). In particular, this role will (a) provide strategic device regulatory decisions on strategies and risk management of the diagnostic device and AI/ML product portfolio throughout the entire product lifecycle, (b) solve unique and strategic challenges with broad impact on the growing diagnostic device portfolio in a dynamic regulatory environment, and (c) establish trusted relationships with industry partners and interface with health authorities with the goal to influence industry best practices and regulatory landscape intentionally.

This position requires in depth and breadth of US device regulatory knowledge and experience throughout the product life cycle, strong leadership, critical thinking, collaboration and influencing skills. Ex-health authority regulatory experience is highly desirable.