Post Market Surveillance Recall Specialist

Merit Medical Systems • South Jordan, UT

6d • Onsite

About The Position

This role is responsible for maintaining and implementing process improvements for the Global Adverse Event reporting system and related duties. It also involves assisting with other post-market surveillance activities as required. The specialist will lead and coordinate product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions (FSCAs), developing strategies, execution plans, communication plans, and timelines. This involves cross-functional coordination with various departments including Quality, Regulatory Affairs, Post Market Surveillance, Clinical Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, Distribution, Commercial Organizations, Legal, and International Affiliates. The role also supports the identification of affected lots, serial numbers, distribution channels, and customer populations, as well as the coordination of product quarantine, inventory control, and disposition. Ensuring timely execution of recall planning, customer notifications, effectiveness checks, product recovery, reconciliation, and termination is crucial. The specialist will manage product returns, corrections, replacements, and destruction, ensuring returned product reconciliation and maintenance of Certificates of Destruction. Monitoring progress and effectiveness metrics, escalating issues, and conducting effectiveness checks to verify customer receipt and implementation of recall actions are key responsibilities. The role involves publishing routine recall metrics and preparing data for management review, ensuring compliance with global regulations such as FDA 21 CFR Part 803, 806, Part 7, Quality System Regulation (21 CFR Part 820), EU MDR 2017/745, Canadian Medical Device Regulations, Australian TGA Requirements, and ISO 13485. The specialist will prepare, submit, and maintain documentation, interface with global regulatory bodies and internal stakeholders, and support regulatory inspections and audits. Coordination with regional RAQA representatives regarding field actions and reporting obligations is also required.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Biomedical Sciences, or a related discipline.
• Minimum of 3-5 years of experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling, adverse event reporting, 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, and 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.

Responsibilities

• Maintains and implements process improvements for the Global Adverse Event reporting system and duties related to the reporting system.
• Assists with other post market surveillance activities as required.
• Lead and coordinate product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions (FSCAs).
• Develop recall strategies, execution plans, communication plans, and implementation timelines.
• Coordinates 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.
• Works cross-functionally with Operations or other teams to identify affected lots, serial numbers, distribution channels, and customer populations impacted.
• Supports the coordination of product quarantine, inventory control, and product disposition activities.
• Ensure timely execution of recall planning, customer notifications, effectiveness checks, product recovery activities, reconciliation activities, recall termination and closure activities.
• Manages product returns, product corrections, replacements, and destruction activities.
• Ensures returned product reconciliation and maintenance of Certificates of Destruction (CODs).
• Monitors progress and effectiveness metrics and escalates issues that may impact successful field action execution.
• Conduct effectiveness checks to verify customer receipt and implementation of recall actions including, but not limited to, recall response rates, product recovery rates, adverse event reporting compliance, recall performance metrics, and periodic update reports.
• Publishes routine recall metrics for management and prepares relevant data for management review.
• Ensure compliance with applicable regulations and standards, including, but not limited to FDA 21 CFR Part 803 – Medical Device Reporting, FDA 21 CFR Part 806 – Medical Device Corrections and Removals, FDA 21 CFR Part 7 – Recall Guidance, FDA Quality System Regulation (21 CFR Part 820), EU MDR 2017/745 Vigilance and FSCA Requirements, Canadian Medical Device Regulations, Australian Therapeutic Goods Administration (TGA) Requirements, ISO 13485 Quality Management System requirements and other related global regulatory reporting and vigilance requirements.
• Prepares, submits and maintains documentation including plans, communications, response forms, related emails, regulatory reports (806, FSCA, etc.) and other notifications to FDA and international regulatory authorities.
• Interfaces with global regulatory bodies and internal stakeholders.
• Supports regulatory inspections, notified body audits, and government agency inspections related to field action activities.
• Maintains inspection-ready documentation and records.
• Coordinate with regional RAQA representatives regarding field actions and reporting obligations.

Benefits

• Medical/Dental & Other Insurances
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level