Post Market Surveillance Recall Specialist
Merit Medical · South Jordan, UT
SafetyFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Merit Medical seeks a Post Market Surveillance Recall Specialist to lead and coordinate product recalls, field safety corrective actions, and adverse event reporting. The role involves managing cross-functional recall execution, regulatory compliance across FDA, EU, and international standards, and ensuring timely closure of field actions.
What they're looking for
- Bachelor's degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, or related discipline
- 3-5 years experience in medical device quality, regulatory affairs, or post-market surveillance with field action focus
- Global medical device field action recall execution experience
- Strong knowledge of FDA 21 CFR 803, 806, Part 7, EU MDR 2017/745, ISO 13485, and Canadian regulations
- Project management, organizational, and time management skills
- Excellent written and verbal communication abilities
- Proficiency with quality systems, databases, spreadsheets, and Microsoft Office
What you'll be doing
- Lead and coordinate recalls, corrections, removals, market withdrawals, and field safety corrective actions
- Develop recall strategies, execution plans, communication plans, and implementation timelines
- Coordinate cross-functionally with Quality, Regulatory Affairs, Manufacturing, Supply Chain, and other departments
- Conduct effectiveness checks to verify customer receipt and measure recall performance metrics
- Prepare and submit regulatory documentation and reports to FDA and international authorities
Privacy & handoff
This role links to Merit Medical's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.