Post Market Surveillance Recall Specialist

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.

Responsibilities

• 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

Requirements

• 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