Senior Regulatory Affairs Specialist

Accountabilities:

• • Lead and support regulatory and quality strategies for product development, approvals, launches, and lifecycle management across wellness and regulated product features.
  • Support regulatory operations for SaMD products throughout development, submission, launch, and post-market phases.
  • Coordinate the preparation, compilation, publishing, submission, and archival of regulatory applications, correspondence, and supporting documentation.
  • Maintain accurate regulatory records, including submission trackers, product registrations and listings, regulatory commitments, approval and clearance records, and change assessment logs.
  • Support design change assessments and evaluate the potential regulatory impact of software updates, labeling changes, and other product modifications.
  • Track and communicate regulatory milestones, approvals, renewals, commitments, 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 remains complete, accurate, and current.
  • Monitor evolving regulations, regulatory guidance, and industry standards relevant to SaMD and translate changes into actionable operational requirements.
  • Collaborate with Quality, Engineering, Product, Clinical, Legal, and other stakeholders to improve regulatory processes, templates, tools, and workflows.
  • Help strengthen scalable regulatory operations and promote efficient, compliant execution across the product lifecycle.

  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 another regulated healthcare product environment.
  • Hands-on experience supporting software-based medical products or Software as a Medical Device (SaMD).
  • Working knowledge of key regulatory frameworks and standards, including FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971.
  • Experience compiling, maintaining, and managing regulatory documentation within a controlled environment.
  • Strong project coordination, organization, documentation, and deadline-management skills.
  • Exceptional attention to detail and a strong commitment to accuracy and compliance.
  • Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and non-technical teams.
  • Ability to manage multiple priorities in a fast-paced environment while maintaining high-quality work.
  • Experience supporting 510(k), De Novo, technical documentation, or international regulatory registrations is preferred.
  • Familiarity with eQMS, document control, and regulatory submission management tools is a plus.
  • Experience with software change assessments, traceability, and product lifecycle documentation is advantageous.
  • Understanding of cybersecurity, labeling, and post-market requirements for SaMD is preferred.
  • RAC certification or relevant regulatory training is a plus.
  • Experience working within a startup or high-growth medtech environment is desirable.

  Benefits:

  • Competitive salary and equity packages.
  • US market-based compensation determined by location, skills, experience, qualifications, internal equity, and market conditions.
  • Region 1: $151,300–$178,000.
  • Region 2: $138,550–$163,000.
  • Region 3: $127,500–$150,000.
  • Health, dental, and vision insurance.
  • Mental health and well-being resources.
  • Company-provided wearable health device and employee discounts for friends and family.
  • 20 days of paid time off.
  • 13 paid holidays.
  • 8 days of flexible wellness time off.
  • Paid sick leave and parental leave.
  • Opportunity to work in a fast-growing digital health and medical technology environment.
  • Inclusive workplace committed to equal employment opportunities and reasonable accommodations.
  • Location eligibility: Candidates residing in Alaska, Delaware, Iowa, Mississippi, Nebraska, South Dakota, West Virginia, or Wisconsin are not currently considered.