Specialist, Regulatory Affairs - Irvine, United States - Edwards Lifesciences

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 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

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 $70,000 to $100,000 (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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.

As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.

If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination.

In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.

Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.

Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work.

From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.