Director, Regulatory Counsel — MedTech Contracts & Compliance

Edwards Lifesciences; Washington (District of Columbia); On-site; USD 174,000 - 246,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences in Irvine, California, seeks a Director, Regulatory Counsel to provide timely legal guidance on advertising, promotions, and clinical contracts across business units. You will partner with Marketing, Regulatory Affairs, Compliance and Clinical Affairs to minimize risk while supporting product development.

The role requires a JD with 8 years of experience, strong communication, problem-solving, and ability to lead cross-functional teams in a fast-paced environment.

Qualifications

• 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 clearly 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.

Responsibilities

• Provide legal guidance to Edwards to Marketing, Clinical Affairs, Regulatory Affairs, Compliance and other functions regarding advertising and promotional materials to determine compliance and mitigate risk.
• Provide advice and counsel with respect to fraud and abuse issues.
• Review and advise on clinical contracts and various 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; build knowledge base for Healthcare Regulatory team.
• Develop and deliver legal education to business colleagues on regulatory pathways and FDA processes.
• Monitor regulatory developments affecting Healthcare Regulatory and medical device spaces and build expertise.
• Other duties as assigned.

Skills

Written and verbal communication

Interpersonal skills

Problem solving

Strategic thinking

Team player

Prioritization under pressure

Education

Juris Doctor (ABA-accredited)

Tools

None

Job description

Edwards Lifesciences in Irvine, California, seeks a Director, Regulatory Counsel to provide timely legal guidance on advertising, promotions, and clinical contracts across business units. You will partner with Marketing, Regulatory Affairs, Compliance and Clinical Affairs to minimize risk while supporting product development.

The role requires a JD with 8 years of experience, strong communication, problem-solving, and ability to lead cross-functional teams in a fast-paced environment.