Director, Regulatory Counsel

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 174,000 - 246,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Director, Regulatory Counsel to lead review and approval of advertising and promotional materials, provide guidance on fraud and abuse issues, and advise on clinical contracts and regulatory filings.

You will partner with Marketing, Clinical Affairs, Regulatory Affairs and Compliance to align business objectives with regulatory requirements, develop and harmonize standard processes, and educate colleagues on pathways to market (510(k), PMA) and FDA

Qualifications

• Juris Doctor from ABA-accredited law school.
• 8 years of experience in a legal role at a law firm or in-house.
• Strong written and verbal communication; ability to convey complex legal concepts to business leaders.
• Excellent independent problem-solving, critical thinking, and investigative skills.
• Strategic thinking, proactive mindset, and ability to work under pressure.
• Team player and trusted business partner.

Responsibilities

• Provide legal guidance on advertising and promotional pieces for regulatory compliance.
• Advise on fraud and abuse issues in the medical device/pharmaceutical space.
• Review and negotiate clinical and strategic contracts across business units.
• Develop and harmonize standard processes, templates, and knowledge bases for Healthcare Regulatory.
• Deliver legal education on regulatory pathways (e.g., FDA) and compliance.
• Monitor developments in Healthcare Regulatory and medical device regulations.

Skills

Written and verbal communication

Problem-solving

Critical thinking

Strategic thinking

Team player

Prioritization under pressure

Education

Juris Doctor (ABA-accredited)

Job description

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).Work Schedule: Given the collaborative and complex nature of this work, this role is in person full time in Irvine, California.How you’ll make an impact: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 unitsDeveloping 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.What you'll need (Required):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 skillsStrategic 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 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.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 (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). 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.