Director, Regulatory Counsel — Life Sciences

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

Benefits offered by this job

Competitive salary

Incentives

Benefits program

Job summary

Edwards Lifesciences in Irvine, California is seeking a Director, Regulatory Counsel to lead regulatory review of advertising and promotional pieces and provide counsel across marketing, clinical affairs and regulatory teams. This role is in-person, full-time, and requires broad regulatory expertise.

The successful candidate will negotiate clinical and commercial contracts, guide promotional activities, and stay current on FDA pathways and healthcare regulations while partnering with multiple

Qualifications

• Juris Doctor from ABA-accredited law school.
• 8+ years of legal experience at a law firm or in-house.
• Strong written and verbal communication and interpersonal skills.
• Excellent independent problem-solving, critical thinking and investigative skills.
• Strategic thinking, proactive mindset and collaboration with business teams.

Responsibilities

• Provide legal guidance to Edwards across business units and corporate functions.
• Review advertising and promotional materials for regulatory compliance and risk.
• Review, negotiate, and advise on clinical and commercial contracts across units.
• Develop and harmonize standard processes and templates; maintain a knowledge base.
• Develop and deliver legal education on regulatory approvals and FDA pathways.
• Monitor regulatory developments in healthcare and medical devices.
• Perform other duties as assigned.

Skills

Written communication

Verbal communication

Interpersonal skills

Problem solving

Strategic thinking

Team player

Prioritization

Pressure management

Education

Juris Doctor

Job description

Edwards Lifesciences in Irvine, California is seeking a Director, Regulatory Counsel to lead regulatory review of advertising and promotional pieces and provide counsel across marketing, clinical affairs and regulatory teams. This role is in-person, full-time, and requires broad regulatory expertise.

The successful candidate will negotiate clinical and commercial contracts, guide promotional activities, and stay current on FDA pathways and healthcare regulations while partnering with multiple