Sr Product Recall Specialist
Core
Leads and oversees complex product recall activities, serving as a subject matter expert for FDA-regulated notifications and company-initiated recalls.
Role type
Senior Product Recall Specialist
Builds
Compliant recall execution processes and regulatory communication workflows
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
FDA recall regulations expertise, regulatory agency liaison, audit readiness, 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 coordinate sub-recall notifications and company-initiated recall activities; Serve as primary liaison between the company and the FDA district office; Manage and respond to FDA effectiveness checks and regulatory inquiries; Organize and oversee returned product areas; Issue and oversee return labels, RGAs, credits, and replacement products; Conduct internal audits of recall activities; Train and mentor Recall Specialists; Collaborate with Quality Control to secure affected product; Prepare periodic recall status reports and metrics.
Seniority
Senior, hands-on IC
