Senior Product Recall Specialist
Core
Lead and oversee complex product recall activities, serving as a subject matter expert for FDA-regulated notifications and company-initiated recalls.
Role type
Senior operational specialist (product recall)
Builds
Compliant recall execution and regulatory reporting
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
FDA recall regulations, regulatory documentation, audit readiness, product segregation, vendor reconciliation, process improvement, training and mentoring, cross-functional collaboration
Preferred skills
Associate or Bachelor's degree in a related discipline
Technologies
Microsoft Outlook, Word, Excel
Responsibilities
Lead and execute sub-recall notifications and company-initiated recall activities; Serve as primary liaison between the company and the FDA district office; Manage FDA effectiveness checks and regulatory inquiries; Organize returned product areas and oversee return labels/credits; Provide direction to Quality Control to identify and secure affected product; Conduct internal audits of recall activities; Train and mentor Recall Specialists.
Seniority
Senior, hands-on IC