Edwards Lifesciences
Senior Specialist, Regulatory Affairs THV
USA - California – Irvine · Senior
Sponsorship not specified$92k-$130kDetected 8 hours ago
Patient CareFDA RegulatoryMedical DevicesPublic SpeakingRegulatory Affairs
About the role
- Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.
Responsibilities
- Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
- Track timelines and documents milestone achievements for inclusion in regulatory submissions.
Requirements
- Bachelor's Degree & a minimum of 5 years related experience OR equivalent work experience based on Edwards criteria
- Experience in preparing domestic & international product submissions
- A Bachelor's degree in a scientific discipline
Skills
- Make a meaningful difference to patients around the world.
- Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated.
- It's our driving force to help patients live longer and healthier lives.
Compensation
- May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files)
Benefits
- Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
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This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.