Manager, Regulatory Counsel

Make a meaningful difference to patients around the world! Our Legal team works to protect our patients, team members, and innovations with the utmost diligence and care. You’ll have the opportunity to work with a dedicated team and build lasting partnerships with stakeholders across our global organization. Your legal knowledge and contributions will help us ensure that we are supporting the needs and interests of the patients we serve.

The Manager, Regulatory Counsel reports to the Senior Director, Regulatory Counsel and will be responsible for timely review and analysis of advertising and promotion pieces as well as assisting with other legal regulatory tasks as needed. The Manager, Regulatory Counsel will closely partner with Marketing, Regulatory Affairs, Compliance and other functional groups within Edwards, and will require a thorough understanding of each of Edwards’ business units and the products they manufacture and sell. The successful candidate will have a unique opportunity to help Edwards achieve its business objectives by providing practical, timely and effective legal counsel, while minimizing potential legal risks (and having fun doing it as part of a great team).

Work Schedule: Given the collaborative and complex nature of this work, this role is in person full time in Irvine, California with flexibility to occasionally work from home as needed.

You will make an impact by...

Providing legal guidance to Edwards, including working closely with the Marketing teams in each of the business units (Transcatheter Heart Valves, Transcatheter Mitral and Tricuspid Technologies, Surgical Structural Heart) and Advanced Technology, and other Business Unit or Corporate functions such as Regulatory Affairs, Compliance, and others.

• Reviewing and advising on a variety of advertising and promotional pieces, including print and digital ads, social media campaigns, speaker presentations, and other materials to determine compliance with applicable regulations and policies and assess corporate risk.
• Developing and harmonizing standard processes and templates; creating, improving, and institutionalizing knowledge base for the Healthcare Regulatory team.
• Developing and delivering legal education to business colleagues in specific areas (e.g., regulatory approval processes, pathways to market (510(k), PMA, etc.), contract negotiation and drafting, etc.).
• Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces.
• Other duties and responsibilities as assigned.

What you'll need (Required):

• Juris Doctor from ABA-accredited law school with 3 years of legal experience at a law firm or in-house legal department.
• Strong communication and interpersonal skills, including the ability to convey complex legal and transactional concepts/issues clearly and succinctly to legal and business decision makers.
• Excellent independent problem-solving, critical thinking, and investigative skills
• Strategic thinking, proactive mindset, and excellent problem-solving abilities.
• Ability to be a team player and a trusted business partner.
• Ability to work under pressure and prioritize projects and tasks appropriately.

What else we look for (Preferred):

• Background in life sciences, MedTech, pharmaceuticals, or related healthcare industry experience preferred
• Experience reviewing advertising and promotional materials in the medical device or pharmaceutical industry.

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 $120,000 to $170,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

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.