Principal Regulatory Affairs Program Specialist
ZOLL Medical Corporation(1 day ago)
About this role
A Principal Regulatory Affairs Program Specialist at ZOLL supports regulatory strategies and submissions for medical devices, ensuring compliance and facilitating global market entry. The role involves acting as a technical liaison, developing regulatory strategies, and collaborating across teams to support product development and commercialization.
Required Skills
- Regulatory Strategy
- Medical Devices
- Submission Writing
- FDA
- Risk Management
- Global Registrations
- Technical Documentation
- Cross-Functional Collaboration
- Quality Assurance
- Standards Compliance
Qualifications
- Bachelor's Degree in Science or Engineering
- 8+ years of regulatory experience
- 3+ years in electro-mechanical or software medical products
- Submission writing experience
- Regulatory Affairs Certification (preferred)
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