Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Alaska, +7 more states.

📋 Description

• Oversee the regulatory and quality strategy for the development, approval, and lifecycle management of wellness and regulated features.

• Assist the regulatory operations lead for Software as a Medical Device (SaMD) products throughout the development, submission, launch, and post-market phases.

• Coordinate the preparation, compilation, publication, and archiving of regulatory submissions and associated correspondence.

• Maintain regulatory documentation, which includes submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, as well as change assessment logs.

• Aid in design change assessments and evaluate the regulatory filing implications for software updates, labeling alterations, and product modifications.

• Monitor and communicate submission milestones, approvals, renewals, and post-market reporting obligations.

• Assist with UDI, registration, listing, and market access maintenance activities as applicable.

• Enhance inspection and audit readiness by organizing regulatory evidence and ensuring that documentation is current and prepared for inspection.

• Keep track of evolving regulations, guidance, and standards pertinent to SaMD, and facilitate the translation of changes into operational actions.

• Collaborate with cross-functional teams to refine regulatory processes, templates, and tools for scalability and efficiency.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or a related field.

• Over 5 years of experience in regulatory affairs or regulatory operations in medical devices, digital health, or other regulated healthcare products.

• Experience in supporting software-based medical products or SaMD.

• Knowledge of FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971.

• Proven experience in compiling and managing regulatory documentation within a controlled environment.

• Strong skills in project coordination, organization, and document management.

• Exceptional written and verbal communication abilities.

• Capability to handle multiple priorities and deadlines with meticulous attention to detail.

• Experience in supporting 510(k), De Novo, technical documentation, or international registrations.

• Familiarity with eQMS, document control, and submission management tools.

• Experience in 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 advantageous.

• Preferred experience in a fast-paced startup or rapidly growing medtech environment.

🏝️ Benefits

• Competitive salary and equity packages.

• Health, dental, vision insurance, and mental health resources.

• An Oura Ring of your own, along with employee discounts for friends and family.

• 20 days of paid time off, plus 13 paid holidays, and 8 days of flexible wellness time off.

• Paid sick leave and parental leave.