Senior Specialist, Regulatory Affairs, Critical Care

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.

How you will make an impact:

As a Senior Specialist, Regulatory Affairs, you work with other functional areas as the regulatory expert to provide regulatory guidance throughout the R&D and clinical process, for each of our critical care devices in NPD stages. You manage all Regulatory Affairs activities within the US, EU and respective countries. At Edwards, you work on some of the most innovative algorithm and software technologies transforming cardiovascular patient care.

• Planning multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion within scope of project deliverables

• Representing the regulatory function on manufacturing and product development teams providing input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions

• Reviewing and approving protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy

• Providing direction and guidance to smaller project teams to execute tactical regulatory affairs projects and/or initiatives including preparation and oversight of documentation packages for submission to regulatory agencies

• Tracking timelines and documents for inclusion in regulatory submissions; may interact with regulatory agencies as part of submission review and on-site audit support

• Identifying and evaluating regulatory affairs process improvements and/or course correction/course alignment opportunities

• Developing strategies and contingency plans for projects

• Facilitating Edwards’ introduction of proposed and current global regulations and guidance; may advise on impact of such regulations on the company and may implement solutions

• 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 promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy

What you'll need (Required):

• Bachelor's Degree AND 5 years previous related experience OR

• Master's Degree AND 3 years related experience

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 with strong input/authoring 510(k)s strongly preferred

• Regulatory affairs experience with software devices