Director, Regulatory Counsel

Edwards Lifesciences; San Diego (CA); Presencial; USD 174 000 - 246 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Relocation assistance

Resumo da oferta

Edwards Lifesciences in Irvine, CA is seeking a Director, Regulatory Counsel to lead regulatory review of advertising, provide strategic legal counsel to Marketing, Clinical Affairs and Regulatory Affairs, and help minimize risk across Edwards’ medical devices.

This in-person, full-time role offers relocation for qualified candidates and requires a JD with 8 years of experience in regulatory law, with ability to collaborate across business units.

Qualificações

• Juris Doctor from ABA-accredited law school with 8 years of legal experience.
• Strong written and verbal communication, and interpersonal skills.
• Ability to work under pressure and manage priorities.

Responsabilidades

• Review and approve advertising and promotional materials for compliance.
• Provide guidance on fraud and abuse issues.
• Review clinical contracts and regulatory matters.
• Assist with state licensing and sales contracting support.
• Develop standard processes and knowledge base for Healthcare Regulatory team.
• Deliver legal education on regulatory pathways and FDA investigations.
• Monitor regulatory developments affecting healthcare and medical devices.

Conhecimentos

Juris Doctor

8+ years experience

Regulatory law

Contract review

Communication skills

Formação académica

Juris Doctor (ABA-accredited)

Descrição da oferta de emprego

USA - California – Irvine

USA - Penn - Philadelphia

USA - California – San Francisco

USA - California – San Diego

USA - Washington, District of Columbia

USA - New York – New York City

Full time

Req-49848

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. Relocation will be provided for qualified candidates.

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 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.

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 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 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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.