Senior Regulatory Affairs Specialist

Job Summary

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