A client in the Lebanon, TN area is looking for a Field Action/Recall Project Manager to join their team. This is a full-time opportunity and will be hybrid (3 days a week) in Lebanon. Please find key responsibilities below:
Monitor and track the progress of field actions, ensuring timely and effective completion
Collaborate with a team of regional and country field action coordinators, to ensure global execution
Ensures timely submission of recall notifications and responses to customers
Provides clear and concise communication to internal and external stakeholders regarding field actions and product recalls
Coordinates periodic recall meetings with stakeholders and provides regular updates/metrics to management on progress
Works with cross-functional teams (QA, Legal, Supply Chain, Sales, Customer Service) to manage recall operations and logistics
Maintain accurate and detailed records of field actions and associated activities
Ensures monthly reports are submitted to Health Authorities, when required
Works with finance to ensure recall expenses are in line with budget
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35 years of experience in regulated industry.
Medical device recall experience
In-depth knowledge of FDA recall requirements (21 CFR 806), cGMPs, and quality systems.
Strong project management and organizational skills.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.