Senior Regulatory Affairs Specialist
$92,000–$138,000 year
Remote · United States
Job Summary
Lead global regulatory projects for medical devices, developing regulatory strategies for new launches, post-market changes, and ongoing compliance. Coordinate cross-functional teams to prepare and maintain regulatory submissions (510(k) and CE Technical Files), evaluate regulatory requirements, monitor changes in regulations, communicate requirements to internal/external stakeholders, and guide evidence substantiation, labeling/claims, and audit readiness. Define timelines, pathways, and actions for diverse products, support internal databases and records, and participate in audits. Requires up to 10% travel and a B.S./B.A. in a life-science or related field with 4+ years of regulatory affairs experience in the medical device sector.
Required Qualifications
- B.A. or B.S. in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
- At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets
- Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
- Experience preparing responses and communicating with regulatory agencies
- Understanding of the current Regulatory environment and demonstrating the ability to perform within
- Applied knowledge of FDA regulations and guidelines
- Ability to evaluate information to determine compliance with standards, laws, and regulations
- Position requires up to 10% travel
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