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Specialist, Regulatory Affairs

3 months 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 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.

Preparing documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions

Representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.

Strategizing and presenting alternatives for meeting regulatory requirements within regulatory affairs and cross-functionally

Resolving conflicts between those requirements and development issues

Advancing complex situations to management for guidance and training opportunities

You will prepare and oversee documentation packages for submission to global regulatory agencies

Tracking timelines and documents milestone achievements for inclusion in regulatory submissions.

You 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)

Providing guidance on regulatory requirements necessary for contingency planning

Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s); proposing suggestions on utilizing regulatory updates to expedite approval process

Reviewing 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 previous related experience OR Bachelor’s degree and 3 years of previous related experience

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

**What else we look for (preferred)**:
Master’s degree in scientific discipline and 1 year of preparing (writing) domestic and international submissions

Bachelor’s degree in scientific discipline and 3 years preparing (writing) domestic and international submissions

Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III

Solid knowledge of global regulatory requirements for new products or product changes

Solid knowledge of new product development systems