Director, Regulatory Counsel

Edwards Lifesciences•Irvine, CA

3d•$174,000 - $246,000•Onsite

About The Position

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 Director, Regulatory Counsel reports to the Vice President, Regulatory Counsel and will be responsible for timely review and approval of advertising and promotion materials, provision of advice and counsel with respect to fraud and abuse issues, analysis of clinical contracts, assistance with state licensing, support for sales contracting, and other legal regulatory duties as needed. The Director, Regulatory Counsel will closely partner with Marketing, Clinical Affairs, 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).

Requirements

Juris Doctor from ABA-accredited law school with 8 years of legal experience at a law firm or in-house legal department.
Strong written and verbal communication and interpersonal skills, including the ability to convey nuanced legal 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.

Nice To Haves

Background in life sciences, MedTech, pharmaceuticals, or related healthcare industry experience preferred.
Experience in advertising and promotion in the medical device or pharmaceutical industry or at a healthcare system.
Experience providing advice and counsel with respect to fraud and abuse issues in the medical device or pharmaceutical industry.
Prior-in house experience in life sciences, MedTech, pharmaceuticals, or related healthcare industry preferred.

Responsibilities

Providing legal guidance to Edwards, including working closely with each of the business units and Corporate functions.
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.
Providing advice and counsel with respect to fraud and abuse issues.
Reviewing and advising on clinical contracts and a variety of legal issues related to clinical trials.
Reviewing, negotiating, and advising on strategic clinical and commercial contracts across business units
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.), requirements for FDA-regulated clinical investigations, etc.).
Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces and developing expertise in strategic focus areas.
Other duties and responsibilities as assigned.