Senior Specialist, Regulatory Affairs THV at Edwards Lifesciences Irvine, CA

Senior Specialist, Regulatory Affairs THV job at Edwards Lifesciences. Irvine, CA. 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 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 moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions.
• 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., IDEs, PMAs, annual reports, 510(k) s, STEDs 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.

• Bachelor's Degree
• A minimum of 5 years of previous related experience

• Experience in preparing domestic and international product submissions
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Excellent problem‑solving, organizational, analytical and critical thinking skills
• Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Full knowledge and understanding of global regulatory requirements (US, EU, and Health Canada) for new products or product changes
• Full knowledge of new product development systems

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 $90,000 to $127,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient‑facing and in‑hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.

This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.