Manager, Regulatory Affairs THV

Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated. 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. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Represent the THV regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy

• Prepare, provide direction and oversee documentation packages for submission to global regulatory agencies. Prepare GUIDID submission data. Track timelines and documents milestone achievements for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on-site audit support. (e.g., ITA's, IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)

• Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions

• Review promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy

• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process

• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on multiple projects, propose suggestions and lead the implementation on utilizing regulatory updates to expedite approval process

What you will need (Required):

• Bachelor's Degree and a minimum of 8 years related experience or equivalent work experience based on Edwards criteria

• Coursework, seminars, and/or other formal government and/or trade association training or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• Master's Degree and a minimum of 6 years related experience or equivalent work experience based on Edwards criteria

• Previous PMA & IDE experience

• Experience in preparing domestic and international product submissions preferred or equivalent work experience based on Edwards criteria

• Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry)

• Extensive knowledge and understanding of global regulations relevant to Class III medical devices

• Extensive knowledge and understanding of global regulatory requirements for new products or product changes

• Extensive knowledge of new product development systems

• Ability to interact with regulatory agencies and international regulatory partners