Edwards Lifesciences Regulatory Counsel in Irvine, California
The Regulatory Counsel position is a blend of clinical and regulatory responsibilities who will report to the Lead Regulatory Counsel. The successful candidate will facilitate the business objectives of Edwards by providing practical, timely and effective legal support, while minimizing potential legal risks. Under the supervision of Senior Attorneys, the successful candidate will provide high quality guidance and support to Edwards’ clinical, regulatory, and quality assurance teams and business units on healthcare and medical device regulatory matters such as:
FDA regulatory matters
Clinical Trials and negotiation
Advertising and promotion
Healthcare fraud and abuse
Other essential job functions include:
Participation in investigations when appropriate.
Work in close cooperation with the Associate General Counsel to coordinate and streamline efforts.
Develop a thorough understanding of and familiarity with: Edwards’ business, its people, products, markets, facilities, customers and competitors and use this knowledge in providing guidance and counsel to Edwards clients.
Identify training needs and assist in development and presentation of training and education regarding regulatory requirements and developments.
Perform special assignments or projects if necessary.
Perform other duties and responsibilities as assigned.
Graduation from ABA accredited law school with top academic credentials.
Licensed and admitted to practice law in good standing in at least one U.S. state.
At least 3-5 years of experience in private practice, in-house counsel and/or government (FDA).
Demonstrated experience in FDA regulatory law.
Demonstrated experience in clinical trials.
Ability to analyze and interpret efficacy and safety data.
Familiarity with privacy and data protection.
Decision-making ability and experience.
Problem solver—able to find practical solutions and provide practical guidance.
Accountable and hands-on, self-starter, results oriented.
Desire to understand products and business.
Excellent oral and written communication skills with the ability to gain the trust of and form solid relationships with various business clients and Legal Department colleagues.
Able to manage several high-priority projects simultaneously.
Some experience with US device marketing, advertising and promotion regulations.
At least 2-3 years as in-house counsel in medical device industry.
General understanding of medical device regulation outside of the U.S.
Deep experience in global privacy and data protection matters.
About EdwardsEdwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Regulatory Counsel Location: USA-USA-California - Irvine Job Number: 009196