Manager, Regulatory Affairs THV

Edwards Lifesciences • Irvine, CA

1d • Onsite

About The Position

This role offers the opportunity to make a meaningful difference to patients globally by guiding innovative technologies through complex domestic and international regulatory environments. Working with external government and regulatory authorities, and diverse internal stakeholders, the Manager, Regulatory Affairs THV will ensure products reach clinicians and improve patients’ lives. The position is within Edwards’ Transcatheter Heart Valve (THV) business unit, which focuses on pioneering solutions like transcatheter aortic heart valve replacement (TAVR) for patients with aortic stenosis and regurgitation, aiming to transform patient care and help patients live longer, healthier lives.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• competitive salaries
• performance-based incentives
• wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Manager