Director, 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.

About the role

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 role will closely partner with Marketing, Clinical Affairs, Regulatory Affairs, Compliance, and other functional groups within Edwards, requiring a thorough understanding of each of Edwards’ business units and the products they manufacture and sell. The successful candidate will help Edwards achieve its business objectives by providing practical, timely, and effective legal counsel while minimizing potential legal risks.

Responsibilities

• Provide legal guidance to Edwards, including working closely with each of the business units and Corporate functions.
• Review and advise 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.
• Provide advice and counsel with respect to fraud and abuse issues.
• Review and advise on clinical contracts and a variety of legal issues related to clinical trials.
• Review, negotiate, and advise on strategic clinical and commercial contracts across business units.
• Develop and harmonize standard processes and templates; create, improve, and institutionalize knowledge base for the Healthcare Regulatory team.
• Develop and deliver 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.).
• Monitor legal developments applicable to the Healthcare Regulatory and medical device spaces and develop expertise in strategic focus areas.
• Other duties and responsibilities as assigned.

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.

Qualifications

• 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.

Schedule

This role is in person full time in Irvine, California.

Pay

For California (CA), the base pay range for this position is $174,000 to $246,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Benefits

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.