Specialist, Regulatory Affairs THV
Edwards Lifesciences(2 months ago)
About this role
A Regulatory Affairs associate supporting the Transcatheter Heart Valve business unit, ensuring devices meet domestic and international regulatory requirements. The role works with internal development and manufacturing teams and external regulatory authorities to enable product approvals and market access for life‑saving heart valve technologies.
Required Skills
- Regulatory Submissions
- Regulatory Strategy
- Labeling Review
- Global Regulations
- Audit Support
- Documentation
- Contingency Planning
- GUDID Submissions
Qualifications
- Bachelor's Degree
- Government/Trade Association Training
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