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Make a meaningful difference to patients around the world. Our Legal team works to protect our patients, team members, and innovations with the utmost diligence and care. You’ll have the opportunity to work with a dedicated team and build lasting partnerships with stakeholders across our global organization. Your legal knowledge and contributions will help us ensure that we are supporting the needs and interests of the patients we serve.

The Senior Director, Corporate & Regulatory Counsel role is a blend of subject matter legal expert and strong business acumen. The Senior Director, Corporate & Regulatory Counsel will have responsibility to counsel and guide the TAVR business unit and serve in an advisory role for management both in the legal department and across all Edwards. Providing exceptional legal guidance on the Company and TAVR business’s commercial, regulatory, clinical and quality legal issues, this role will also be an integral member of the TAVR team and the Legal Department's Regulatory Practice Group with strategic legal oversight of various cross-functional regional programs. The position will be in the Edwards Headquarters, in Irvine CA and reporting to Senior Vice President, Associate General Counsel, TAVR General Counsel.

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 deep knowledge of global medical device-industry, including the regulatory landscape, authorities and frameworks, including FDA. The role will provide high-quality guidance and support to Edwards’ leaders on medical device commercial, clinical, regulatory, quality and reimbursement related legal matters, including ongoing support of various aspects of advertising and promotion, product development, and post-commercialization issues.

*This is an on-site role based in Irvine, CA

How you will make an impact:

+ Provide high quality guidance and support to Edwards’ on healthcare and medical device regulatory matters, including US and other medical device regulatory landscape, Advertising and promotion, Healthcare fraud and abuse, Antitrust, Anti-corruption and the U.S. Foreign Corrupt Practices Act requirements; assess risks and establish metrics for effectiveness of various programs

+ Subject matter expert for department or assigned to significant client group and serve in an advisory role for senior/executive management and provide counsel and guidance to project teams to execute enterprise-level projects, initiatives and programs (e.g., legal research, recommendations on courses of action, review of material contracts, drafting and negotiating complex agreements, review and interpretation of regulations, document review in litigation, and subject matter specific projects)

+ Close collaboration with various cross functional teams including Medical, Legal and Regulatory review of Advertising and Promotion, Grant Reviews and Program, and other TAVR initiatives; coordinate cross functional, regional teams and drive the implementation of various policies and procedures

+ Work in close cooperation with colleagues in the Law and Compliance departments in their mutual mission to promote and ensure adherence to various laws and regulations around the globe specific to medical device companies (e.g., labeling regulations, anti-kickback laws, false claims laws, 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 the Regional equivalents, 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; provide feedback and guidance to staff on assignments and assigned areas and may manage other attorneys or professionals

+ Perform special assignments or projects if necessary; Provide direction in the development and implementation of new and/or improved enterprise-wide and/or intra-departmental procedures, policies or processes to achieve established goals

+ Other incidental duties

What you will need (required):

+ Juris Doctor, minimum 10 years of previous related experience in a reputable law firm or in-house legal department required. Graduate of an accredited law school required.Other: Relevant industry experience (e.g., medical device, pharmaceuticals, etc.) or in highly regulated environments required

What else we look for (preferred):

+ Excellent analytical, detail-oriented, organized and information seeking skills

+ Excellent organization and time management skills

+ Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

+ Recognized as an external thought leader within strategic function or discipline

+ Expert understanding of related aspects of legal processes and/or systems

+ Strict attention to detail

+ Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

+ Ability to manage competing priorities in a fast-paced environment

+ Ability to represent leadership on enterprise initiatives within multiple area or campaigns, interfacing with project managers, legal team, and leadership team

+ Ability to consult in large program setting within multiple areas or campaigns, deeper or more dedicated technical advisory role, interfacing with senior and executive leadership

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $204,000 to $289,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.