Edwards Lifesciences

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex 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.

As a Manager, Regulatory Affairs, you are responsible for completing and maintaining regulatory approvals and clearances of assigned products.

You will make an impact by…

• Representing the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommending multiple solutions for selection by management. Preparing formal Regulatory Plans. Reviewing and approving protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• Preparing, providing direction and overseeing documentation packages for submission to global regulatory agencies. Preparing GUIDID submission data. Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. Interacting with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).
• Providing guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.
• Reviewing promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• 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
• Monitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on multiple projects, proposing suggestions and leading the implementation on utilizing regulatory updates to expedite approval process.

What you’ll need (Required):

• Master’s degree or equivalent in a related field and 6 years of previous related experience OR
• Bachelor’s degree in a related field and 8 years of previous related experience
• Coursework, seminars and/or other formal government and/or trade association training
• Ability to speak and read Japanese
• PMDA experience

What else we look for (Preferred):

• Experience in preparing domestic and international product submissions
• Extensive knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Extensive knowledge and understanding of global regulatory requirements for new products or product changes.
• Extensive knowledge of new product development systems
• Ability to interact with regulatory agencies and international regulatory partners

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 $111,000 to $158,000 (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.