Senior Director, US Compliance

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