Senior Specialist, Regulatory Affairs TMTT
Edwards Lifesciences(1 month ago)
About this role
A Regulatory Affairs professional supporting the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit, helping to guide medical devices through domestic and international regulatory pathways. The role partners with external regulatory authorities and internal stakeholders to ensure products meet regulatory requirements and reach clinicians to improve patient outcomes. It focuses on regulatory strategy and submission support for Class II/III device technologies.
Required Skills
- Regulatory Submissions
- Regulatory Strategy
- GUDID
- Labeling Review
- Global Regulations
- Product Development
- Documentation Review
- Audit Support
- Project Tracking
Qualifications
- Bachelor's Degree
- Government/Trade Training
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