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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, 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

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 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.