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Senior Specialist, Regulatory Affairs
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- From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments.
- Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options.
- As a Senior Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy.
- Track timelines and documents milestone achievements for inclusion in regulatory submissions.
- In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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