Post Market Surveillance Specialist (Fixed-Term)
Merit Medical · Remote
SafetyRemoteFull-timeCompany career page
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Role summary
Merit Medical seeks a Post Market Surveillance Specialist for a fixed-term role through March 2027. The position involves analyzing adverse events, managing global regulatory reporting, and supporting compliance activities across multiple regulatory frameworks.
What they're looking for
- Bachelor's degree plus three years of quality or regulatory experience
- Knowledge of FDA 21 CFR 803, EU MDR 2017/745, and ISO 13485 standards
- Experience with global adverse event reporting systems (MDR, MPR, Vigilance, TGA)
- Strong attention to detail, time management, and organizational skills
- Excellent verbal and written communication abilities
- Project management experience and proficiency with spreadsheets and databases
What you'll be doing
- Analyze complaints and determine regulatory reportability to global health agencies
- Prepare and submit adverse event reports to regulatory bodies within required timelines
- Coordinate with management and regulatory affairs on reporting processes and requirements
- Maintain records in the Global Quality Assurance adverse event system per procedures
- Support FDA inspections, audits, and post-market surveillance activities as directed
Privacy & handoff
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