Director, Regulatory Counsel
The Director, Regulatory Counsel role is a subject matter expert who will have responsibility for legal guidance on the Company’s regulatory, clinical and quality legal issues and have strategic legal oversight of various cross-functional programs. The position is located at the corporate headquarters in Irvine, California and reporting to Vice President, Assistant General Counsel, General Counsel of Transcatheter Heart Valve business.
The successful candidate will deploy a deep knowledge of the company’s business and collaborate with senior leaders to facilitate the business objectives of Edwards by providing practical, timely and effective legal counsel, while minimizing potential legal risks. This role requires high-quality guidance and support to Edwards’ business functions on medical device clinical, regulatory and quality related legal matters, including ongoing support of various aspects of advertising and promotion, product development, and post-commercialization issues.
Other essential job functions include:
Provide high quality guidance and support to Edwards’ on healthcare and medical device regulatory matters, including:
– FDA (and OUS) regulatory matters
– Advertising and promotion
– Healthcare fraud and abuse
– Coordinate cross functional, regional teams and drive the implementation of various policies and procedures
– Assess risks and establish metrics for effectiveness of various programs
– Close collaboration with various cross functional teams including Medical, Legal and Regulatory review of Advertising and Promotion, Grant Reviews and Program, and Value Based Health Care initiatives.
– Work in close cooperation with colleagues in the Legal Department and Corporate Responsibility departments in their mutual mission to promote and ensure adherence to various laws and regulations specific to medical device companies (e.g., labeling regulations, anti-kickback laws, false claims laws, sunshine laws, HIPAA, OSHA, state law equivalents, foreign corrupt practices laws, foreign laws and regulations) (2) Various applicable codes of conduct such as Edwards Titanium Book (Code of Business Conduct and Ethics) and the AdvaMed Code of Ethics, and (3) Edwards Standard Operation Procedures, guidelines, and working instructions.
– 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
– 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 7 years of experience in private practice, in-house counsel and/or government (FDA)
– Demonstrated experience in medical regulatory law
– Experience with US and Global device marketing, advertising and promotion regulations
– Ability to analyze and interpret efficacy and safety data
– 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
– Able to gain the trust of and form solid relationships with various business clients and Legal Department colleagues
– Able to manage multiple high-priority projects simultaneously
– At least 7 years as in-house regulatory counsel in medical device industry
– Deep experience in U.S. medical device regulation
– General understanding of medical device regulation outside of the U.S.
– Experience with global privacy and data protection of the U.S.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes 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 13,000 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.
Learn more here
Job posted: 2020-09-21