Manager, Regulatory Affairs THV

Regulatory Affairs Team Member

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.

How you will make an impact:

• 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

What you will need (Required):

• 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

What else we look for (Preferred):

• 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

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 $126,000 to $178,000 (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 is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

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.