Senior PSUR Writer
Job Summary
Leading the development and submission readiness of post-market surveillance documentation, the full-time remote Senior PSUR Writer will manage multiple product families while ensuring compliance with regulatory requirements and providing mentorship to junior writers.
Key responsibilities
- Lead the authoring and maintenance of PSURs, PMSPs, and PMSRs
- Interpret and analyze safety data to support risk-benefit evaluations
- Serve as the primary liaison for cross-functional PSUR development activities
Required qualifications
- 5+ years of experience in Medical Writing, Regulatory Affairs, or related fields within the medical device industry
- 3+ years of experience authoring PSURs, PMSRs, or equivalent regulatory documentation
- Advanced knowledge of EU MDR 2017/745, FDA regulations, and ISO standards
- Bachelor's degree in a scientific, technical, or related discipline; advanced degree preferred
- Strong project leadership and stakeholder management skills
Complete Job Description
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