At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.

The Senior Director will lead the US regional compliance team and oversee the US compliance program, providing compliance guidance, training and solutions to regional commercial and marketing groups as well as functional stakeholders including regulatory, medical affairs, clinical affairs, legal, public affairs and finance.  This role will have a strong emphasis on US healthcare compliance principles, anti-kickback statute requirements and the AdvaMed Code.

This role is based at Edwards corporate headquarters in Irvine, California.

How you’ll make an impact:

·       Proactively partner with the business to promote compliance with applicable laws, codes and policies, including the Edwards Code of Conduct, and to foster a strong culture of compliance.

·       Drive efforts to optimize HCP-related policies, processes and systems by identifying opportunities for greater effectiveness and efficiency and developing, proposing and implementing solutions. Influence outcomes and resolutions with business leadership.

·       Set regional compliance strategy and serve as expert on regional compliance matters while ensuring strong collaboration and alignment across the global Compliance function and other functional stakeholders.

·       Lead the US Regional Compliance Committee and ensure appropriate governance around compliance matters while actively participating in other compliance-related committees and meetings (e.g. Grants committees, Edwards Foundation and similar).

·       Lead and support monitoring and auditing of compliance with policies and procedures and ensure remediation plans and actions are executed. Support investigations of alleged misconduct and violations of policy, ensure consistent processing, treatment, and corrective actions within assigned region.

·       Other incidental duties

What you’ll need (Required):

·       Bachelor's Degree in related field with related experience in legal, internal audit, finance, and/or health care compliance 

or

·       Master's Degree or equivalent in related field with related experience in legal, internal audit, finance, and/or health care compliance

What else we look for (Preferred):

·       Juris Doctor or equivalent

·       Expert knowledge and understanding of the Medical Device Industry including the various regulatory agencies, regulatory requirements and legal frameworks in the US.

·       Expert knowledge and ability to provide effective guidance on general compliance, US healthcare compliance, anti-kickback principles, transparency reporting and trade association code requirements.

·       Excellent facilitation and presentation skills

·       Expert understanding of effective compliance program standards

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

·       Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

·       Expert understanding of procedures with extensive and detailed knowledge of company allows for innovative concepts and promoting new ideas

·       Ability to support and solicit input from team members at all levels within the organization

·       Strict attention to detail

·       Proven successful project management skills

·       Adhere to all company rules and requirements

·       Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of compliance to the business

·       Ability to influence the business to adopt new industry requirements seamlessly

·       Ability to develop relationships and leverage them to influence change

·       Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment

·       Ability to dedicate to quality client service and pro-active and responsive to client needs

·       Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

·       Ability to provide leadership and direction to cross-functional teams to successfully implement compliance related solutions

·       Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) require

·       Experience in JDE or SharePoint

·       Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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, the base pay range for this position is $169,000 to $240,000 (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.