Edwards Lifesciences · 5 days ago
Senior Specialist, Regulatory Affairs TMTT
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $127K/yr
5+ years expEdwards Lifesciences is dedicated to making a meaningful difference to patients around the world through innovative technologies in the regulatory affairs domain. The Senior Specialist in Regulatory Affairs for the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit will guide regulatory compliance for product development and manufacturing, ensuring that products meet necessary regulatory requirements and assist with submissions to global regulatory agencies.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions
Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy
Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions. 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)
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
Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
Qualification
Required
Bachelor's Degree & a minimum of 5 years related experience or equivalent work experience based on Edwards criteria
Coursework, seminars, and/or other formal government and/or trade association training
Experience in preparing domestic & international product submissions
Preferred
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes
Experience in preparing domestic & international product submissions
Solid knowledge of new product development systems
Solid knowledge of international regulatory requirements
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
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