Job Description
The Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S. regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This role is critical to the company’s next phase of growth and will lead a significant overhaul of regulatory processes, ensuring the organization is prepared for increased regulatory scrutiny, expanded product claims, and future global market access.

This individual will operate in a lean, evolving environment, where ambiguity is common and ethical decision-making is paramount. The successful candidate will be hands-on, pragmatic, and capable of building structure where little currently exists, while serving as a strategic regulato...