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... more details
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):
In addition to meeting the minimum qualifications above, we strongly prefer candidates who possess these critical skills and background helping us achieve our goals:
What else we look for (Preferred):
Experience with strong input/authoring 510(k)s strongly preferred
Regulatory affairs experience with software devices
Experience with product development
Experience preparing domestic and international product submissions
Basic knowledge and understanding of global regulatory requirements for new products or product changes
Basic knowledge and understanding of domestic and global regulations relevant to Class II and/or Class III medical devices
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.
