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.

Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients. Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their families faster. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This role follows a fixed hybrid work model where employees work on campus and from home on regularly scheduled days. It provides flexibility while maintaining regular, in-person collaboration.

How you'll make an impact:

As a Senior Specialist, International Regulatory Affairs, you complete and maintain regulatory approvals and clearances of assigned products.

• Creating complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; tracking timelines and documenting milestone achievements, developing regulatory strategy, prioritizing strategies/submissions with operating plans as well as ensuring alignment with KOD in countries

• Representing the OUS regulatory function on manufacturing and product development teams to providing input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management

• Providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals

• Providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects, based on prior experience and responses from affiliates

What you’ll need (Required):

• 3 years of previous related experience and Masters degree in related field OR

• 5 years of previous related experience and Bachelor's degree in related field

What else we look for (Preferred):

• Experience preparing domestic and international product submissions

• Bachelors and/or Masters degree in scientific discipline

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

• Full knowledge and understanding of global regulatory requirements for new products or product changes

• 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, 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).

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.

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.