Specialist, Regulatory Affairs THV

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

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.

• 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

• 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

• 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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $72,000 to $102,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.

Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.