Manager, Quality and Regulatory Affairs

Job description

Position Title: Manager, Quality and Regulatory Affairs Department: Quality and Regulatory Affairs: Location: Woodland Hills, CA: Employment Type: Full-Time: Position Overview: The Manager, Quality and Regulatory Affairs will serve as the primary owner of Perin Health’s Quality Management System (QMS) and regulatory compliance strategy. This is a high-impact, hands-on role responsible for maintaining and continuously improving quality systems, ensuring ongoing FDA compliance, managing post-market surveillance activities, and supporting current and future regulatory submissions. The ideal candidate thrives in a startup environment, is comfortable wearing multiple hats, and brings deep experience in both quality management and regulatory affairs for Class II medical devices with embedded software and SaMD components. Key Responsibilities: - Own and maintain the company’s ISO 13485-compliant QMS, including all SOPs, work instructions, policies, and quality records. - Lead design transfer activities, ensuring smooth transition of the Perin Health Patch and software platform from development to production, including process validation, manufacturing documentation, and acceptance criteri...