Post Market Surveillance Recall Specialist
Core
Lead and coordinate product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions (FSCAs) for medical devices globally.
Role type
Post Market Surveillance Recall Specialist
Builds
Global adverse event reporting systems and field action execution plans
Domain
Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Global medical device field action recall execution, FDA regulations (21 CFR 803, 806, Part 7), EU MDR 2017/745, ISO 13485, MDSAP, ISO 14971, Canadian Medical Device Regulations, project management, regulatory reporting, effectiveness checks, cross-functional coordination
Preferred skills
None stated
Technologies
Electronic quality systems, databases, spreadsheets, Microsoft Office
Responsibilities
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; 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; Ensure timely execution of recall planning, customer notifications, effectiveness checks, product recovery activities, reconciliation activities, recall termination and closure activities; Manage product returns, product corrections, replacements, and destruction activities; Ensure returned product reconciliation and maintenance of Certificates of Destruction (CODs); Monitor progress and effectiveness metrics and escalate issues that may impact successful field action execution; Conduct effectiveness checks to verify customer receipt and implementation of recall actions; Publish routine recall metrics for management and prepare relevant data for management review; Ensure compliance with applicable regulations and standards; Prepare, submit and maintain documentation including plans, communications, response forms, related emails, regulatory reports (806, FSCA, etc.) and other notifications to FDA and international regulatory authorities; Interface with global regulatory bodies and internal stakeholders; Support regulatory inspections, notified body audits, and government agency inspections related to field action activities; Coordinate with regional RAQA representatives regarding field actions and reporting obligations
Seniority
Mid-level, hands-on IC