Post Market Surveillance Recall Specialist

About the role

Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. We hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Schedule

Work shift: Day (United States of America). Multiple shifts and hours are available, including Days, Swing (Eve), and Nights.

Responsibilities

• Maintain and implement process improvements for the Global Adverse Event reporting system and related duties.
• Assist with other post‑market surveillance activities as required.
• Lead and coordinate product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions (FSCAs), including developing recall strategies, execution plans, communication plans, and implementation timelines.
• Coordinate field‑action activities with Quality, Regulatory Affairs, Post Market Surveillance, Clinical Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, Distribution, Commercial Organizations, Legal, and International Affiliates.
• Work cross‑functionally with Operations or other teams to identify affected lots, serial numbers, distribution channels, and impacted customer populations.
• Support coordination of product quarantine, inventory control, and product disposition activities.
• Ensure timely execution of recall planning, customer notifications, effectiveness checks, product recovery, reconciliation, recall termination, and closure activities.
• Manage product returns, corrections, replacements, and destruction activities, maintaining Certificates of Destruction (CODs) and reconciliation records.
• Monitor progress and effectiveness metrics; escalate issues that may impact successful field‑action execution.
• Conduct effectiveness checks to verify customer receipt and implementation of recall actions, including response rates, product recovery rates, adverse event reporting compliance, and performance metrics.
• Publish routine recall metrics for management and prepare data for review.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 803, 806, Part 7, FDA QSR (21 CFR Part 820), EU MDR 2017/745, Canadian Medical Device Regulations, Australian TGA requirements, ISO 13485, and related global vigilance requirements.
• Prepare, submit, and maintain documentation such as plans, communications, response forms, emails, regulatory reports (806, FSCA, etc.), and notifications to FDA and international authorities.
• Interface with global regulatory bodies and internal stakeholders; support regulatory inspections, notified‑body audits, and government agency inspections related to field‑action activities.
• Maintain inspection‑ready documentation and records; coordinate with regional RAQA representatives regarding field actions and reporting obligations.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Biomedical Sciences, or a related discipline.
• 3–5 years of experience in medical device quality, regulatory affairs, post‑market surveillance, complaint handling, adverse event reporting, or vigilance reporting with a strong emphasis on field‑action recall activities.
• Experience with global medical device field‑action recall execution.
• Strong working knowledge of FDA regulations (21 CFR 803, 806, Part 7), EU MDR 2017/745, ISO 13485, MDSAP, ISO 14971, and Canadian Medical Device Regulations.
• Strong project management, organizational, and time‑management skills.
• Excellent written and verbal communication skills.
• Strong analytical and decision‑making abilities.
• Proficiency with electronic quality systems, databases, spreadsheets, and Microsoft Office applications.
• Ability to manage multiple priorities and meet regulatory reporting deadlines.
• Physical requirements: sitting, standing, bending, occasional lifting up to 50 lb; frequent use of computers; visual acuity, color perception, depth perception, reading, and peripheral vision sufficient to perform job duties.
• Occasional travel may be required to support audits, investigations, and regulatory activities.

Benefits

• Medical, dental, and other insurances (eligible the first of the month after 30 days).
• Low‑cost onsite medical clinic.
• Two onsite cafeterias.
• Employee garden with gardening classes.
• 3 weeks vacation, 1 week sick‑time, and paid holidays.
• 401(k) plan and Health Savings Account.
• Multiple shift options (Days, Swing, Nights) to choose from.
• Veterans are encouraged to apply; Merit is a Utah Patriot Partner committed to hiring veterans.