Edwards Lifesciences · 9 hours ago
Specialist, Regulatory Affairs THV
Irvine, CA
Full-time
Onsite
Mid Level
$72K/yr - $102K/yr
3+ years expEdwards Lifesciences is dedicated to making a meaningful difference in patients' lives through innovative technologies in regulatory affairs. The Specialist in Regulatory Affairs for Transcatheter Heart Valve will guide products through complex regulatory environments, ensuring compliance and facilitating submissions to global 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 conflicts between those requirements and development issues, and/or reporting to management
Prepare and oversee documentation packages for submission to global regulatory agencies. 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)
Provide guidance on regulatory requirements necessary for contingency planning
Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes 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
Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions
Qualification
Required
Bachelor's Degree & a minimum of 3 years related experience or equivalent experience based on Edwards criteria
Coursework, seminars, and/or other formal government and/or trade association training
Preferred
Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, Bioengineering)
Experience in preparing domestic and international product submissions
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
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs
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
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
BioWorld Financial Watch
2025-12-25
Medical Device Network
2025-12-25
Company data provided by crunchbase