Senior Specialist, Regulatory Affairs THV

Edwards Lifesciences; Irvine (CA); On-site; USD 90,000 - 127,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming patient care through innovative medical technologies. This role in Regulatory Affairs offers the chance to impact lives by ensuring compliance with complex regulations while working on groundbreaking heart valve replacement solutions. You will collaborate with diverse teams, guiding products from development to regulatory approval. Your expertise will help navigate the intricacies of global regulations, making a real difference in patients' lives. If you are passionate about regulatory affairs and want to be part of an inspiring journey, this opportunity is for you.

Qualifications

• 5+ years of experience in regulatory affairs related to medical devices.
• Full knowledge of global regulations for Class II and III devices.

Responsibilities

• Provide regulatory input on product development and manufacturing teams.
• Prepare and oversee documentation packages for global regulatory agencies.

Skills

Excellent written and verbal communication skills

Problem-solving skills

Organizational skills

Analytical skills

Critical thinking skills

Negotiation skills

Education

Bachelor's Degree

Job description

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.

How you’ll make an impact:

1. 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.
2. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans.
3. 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).
4. 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.
5. Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.

What you'll need (Required):

1. Bachelor's Degree.
2. A minimum of 5 years of previous related experience.

What else we look for (Preferred):

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

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 $90,000 to $127,000 (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.