For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.

With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.

As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.

So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.

Appendix: For further detail on the spin-off from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99 (https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspx) .

How you will 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

In addition to meeting the minimum qualifications above, we strongly prefer candidates who possess these critical skills and background helping us achieve our goals:

• Experience with strong input/authoring 510(k)s

• Regulatory affairs experience with software devices and product development

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 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.