Cross-Functional, FDA (Food and Drug Administration), Leadership, Medical Equipment, Project/Program Management, Regulations, Regulatory Submissions
Hiring: Regulatory Affairs Program Manager
Location: MA OR PA OR FL (Hybrid 3 4 Days Onsite)
Type: W2 Contract
Industry: Medical Devices
We're looking for an experienced Regulatory Affairs Program Manager with:
10+ years of Medical Device Regulatory Affairs experience
Regulatory Program Management expertise
Divestiture/Regulatory Separation project experience
FDA 510(k), PMA & Global Regulatory Submissions knowledge
Experience with registration transfers and regulatory compliance
Strong cross-functional leadership and stakeholder management