Post Market Surveillance Recall Specialist

Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to 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. WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES 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. Recall and Field Action Management * 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. Minimum Qualifications * 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... For full info follow application link. EQUAL OPPORTUNITY EMPLOYER M/F/D/V. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled