Senior Specialist, Regulatory Affairs

4 weeks ago

Irvine, United States Edwards Lifesciences Full time

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex 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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. 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: As a Senior Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. 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

What you’ll need (Required): Master’s degree and 6 years of previous related experience

OR

Bachelor’s degree and 8 years of previous related experience

Coursework, seminars and/or other formal government and/or trade association training

What else we look for (Preferred): Experience in preparing domestic and international product submissions

Extensive knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III 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, the base pay range for this position is $88,000 to $124,000 (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.

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