Director Corporate Counsel (Regulatory)

Company: Edwards Lifesciences
Location: Irvine
Posted on: September 12, 2020

Job Description:

Edwards Lifesciences Director Corporate Counsel (Regulatory) in Nyon , Switzerland Job Purpose:

The Director Corporate Counsel (Regulatory Counsel) position will have responsibility for legal regulatory guidance within the Europe/Middle East/Africa/Canada (EMEAC) region. The position is based in Edwards’ European headquarters in Nyon, Switzerland.

The successful candidate will facilitate the business objectives of Edwards by providing practical, timely and effective legal counsel, while minimizing potential legal risks. In cooperation with senior attorneys and senior management, the successful candidate will serve as a subject matter expert, providing high-quality guidance and support to Edwards’ regulatory and quality assurance teams and other business functions on strategic enterprise-level projects within the healthcare and medical device regulatory space, such as:

European regulatory affairs, including the Medical Device Regulation and the roles of Notified Bodies and Competent Authorities, other support of Regulatory Affairs and Quality Assurance, and support for legal regulatory issues of Clinical Affairs in EMEA and Canada

Social media and digital marketing initiatives

Advertising and promotion requirements, including device promotion to various audiences, disease awareness, and discussion of scientific activities as applicable to product labeling in each country in the EMEAC region, and developing training for business partners on such topics

Monitoring of legislative developments on medical device regulation, and collaboration with Government Affairs, Regulatory Affairs, and industry groups on influencing such legislation

Other essential job functions include:

Coordinating with and managing external counsel as required for advice in several jurisdictions

Working in close cooperation with other in-house counsel and with the EMEAC Corporate Responsibility team to coordinate and streamline efforts for global efficiency

Close collaboration with European Business Partners to understand business needs and advance appropriate solutions

Taking primary responsibility for specific projects and/or client groups on matters of moderate to significant complexity

Developing a thorough understanding of and familiarity with Edwards’ business, its people, products, markets, facilities, customers and competitors and using this knowledge in providing guidance and counsel to Edwards business partners

Identifying training needs among business stakeholders and developing / presenting training and education regarding regulatory requirements and developments

Participating in product quality investigations when appropriate

Performing special assignments or projects if necessary

Performing other duties and responsibilities as assigned

Desired Skills and Experiences:

Proficient in English and at least one additional European language e.g. French or German (written and spoken) is preferable

Significant demonstrated experience and expertise in regulatory requirements

At least 8 years of related experience in a top tier law firm and/or as in-house counsel, preferably with substantial experience of working cross-jurisdiction ally

Experienced and capable to work in matrix organization and in a multi -cultural international environment

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 deeply understand products and business

Excellent oral and written communication skills with the ability to gain the trust of and form solid relationships with business partners in various functions as well as Legal Department colleagues

Able to manage multiple high-priority projects simultaneously

Experience across major European jurisdictions’ requirements and best practices for advertising and promoting regulated medical devices

Licensed and admitted to practice law in one European country preferred

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.

USA Cares exists to help bear the burdens of service by providing post-9/11 military families with financial and advocacy support in their time of need.

USA Cares is a national 501(c)(3) non-profit, charitable organization based in Kentucky and registered with the IRS.

Keywords: Edwards Lifesciences, Irvine , Director Corporate Counsel (Regulatory), Other , Irvine, California