Senior Regulatory Affairs Specialist

Supporting regulatory strategy and operations for the Software as a Medical Device (SaMD) portfolio, the full-time remote Senior Regulatory Affairs Specialist will manage regulatory activities throughout the product lifecycle, including submissions, document management, and compliance readiness. Key responsibilities Lead regulatory and quality strategy for product development and lifecycle management of wellness and regulated features Coordinate the preparation and archival of regulatory submissions and maintain essential regulatory documentation Monitor evolving regulations and collaborate with cross-functional teams to enhance regulatory processes and tools Required qualifications Bachelor's degree in a scientific, engineering, healthcare, or related discipline 5+ years of experience in regulatory affairs or operations within medical devices or digital health Experience supporting software-based medical products or SaMD Familiarity with FDA medical device requirements, EU MDR, and ISO standards Experience compiling and maintaining regulatory documentation in a controlled environment