Senior Regulatory Affairs Specialist

We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy/operations for our Software as a Medical Device (SaMD) portfolio. This role will help drive compliant and efficient execution of regulatory activities across the product lifecycle, including submission support, document management, change assessments, registrations, regulatory intelligence, and inspection/audit readiness. The ideal candidate brings hands-on experience in medical device or digital health regulatory affairs, strong operational discipline, and the ability to work cross-functionally with quality, engineering, product, clinical, and legal teams in a fast-paced environment.

Responsibilities

Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features; Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases; Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence; Maintain regulatory documentation, including submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs; Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications; Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements; Support UDI, registration, listing, and market access maintenance activities where applicable; Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-ready; Monitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actions; Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency

Requirements

Bachelor’s degree in a scientific, engineering, healthcare, or related discipline; 5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare products; Experience supporting software-based medical products or SaMD; Familiarity with key regulatory frameworks and standards, such as FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, ISO 14971; Experience compiling and maintaining regulatory documentation in a controlled environment; Strong project coordination, organization, and document management skills; Excellent written and verbal communication skills; Ability to manage multiple priorities and deadlines with strong attention to detail

Nice to have

Experience supporting 510(k), De Novo, technical documentation, or international registrations; Familiarity with eQMS, document control, and submission management tools; Experience with software change assessments, traceability, and lifecycle documentation; Understanding of cybersecurity, labeling, and post-market requirements for SaMD; RAC certification or other relevant regulatory training is a plus; Experience working in a fast-paced startup or high-growth medtech environment is preferred

Benefits

Competitive salary and equity packages; Health, dental, vision insurance, and mental health resources; An Oura Ring of your own plus employee discounts for friends & family; 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off; Paid sick leave and parental leave