WORK SHIFTDAY (United States of America)
SUMMARY OF DUTIESMaintains 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 & 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 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.
Physical Requirements- Sitting, standing, bending, and occasional lifting (up to 50 pounds, where applicable).
- Frequent use of computers and electronic systems.
- 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.
COMMENTS
Infectious Control Risk Category II:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.
