Director, US Healthcare Compliance Business Advisor

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.

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Director, US Healthcare Compliance Business Advisor position is a unique career opportunity that could be your next step towards an exciting future.

This role can be a fully onsite or hybrid role based at our Irvine headquarters.

How you’ll make an impact:

The Director, US Healthcare Compliance Business Advisor provides strategic Compliance expertise, leadership, and trusted business partnership across Edwards’ Ethics and Compliance program, with a focus on U.S. business practices involving interactions with health care professionals and health care organizations.

This partnership-minded Compliance leader will have the opportunity to help guide the US Business organization across several pillars of Edwards’ Compliance program – governance, policies, trainings, communications, and monitoring.  The Director will deliver proactive, solutions-oriented Compliance guidance and collaborate closely with business partners to design and implement robust controls, policies, trainings and communications.

• Serve as a strategic compliance leader, business partner and advisor on standard and complex ethics and compliance business operations and initiatives (e.g., Healthcare Organizations/ Healthcare Professionals interactions); provide directions and guidance to project teams to execute larger ethics and/ or Healthcare professional/ healthcare organization projects, and/ or programs including coaching and knowledge sharing.

• Manage, review, and approve business transactions with healthcare professionals and healthcare organizations, including providing consultative advice; identify, evaluate, and implement refined compliance process improvements and/ or course corrections/ alignment opportunities as deemed necessary.
• Develop and update US compliance policies, guidance, job aids, and other resources for internal stakeholders and update such resource as necessary
• Develop and update US Compliance training plans including the creation of compliance training materials and delivery of instructor-led training
• Assist in US risk assessments, investigations, and monitoring of business activity and track progress to completion of corrective action plans, as needed.
• Lead regional compliance committees; participate in regional industry association meetings; participate in Business committees (Grant Review Committee, Business Unit Leadership Committees, etc.) as deemed necessary; analyze, track, and report key metrics for senior leadership.
• Incidental activities as needed

What you’ll need (Required):

• Bachelor's Degree in related field and 12 years experience in legal, internal audit, finance, and/or health care compliance or equivalent work experience based on Edwards criteria, OR
• Master's Degree or equivalent in related field and 10 years experience in legal, internal audit, finance, and/or health care compliance or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• Experience working in US Healthcare Compliance in a large Medical Device, Pharmaceutical, and/or Biotech company.
• Knowledge of Compliance-related government enforcement trends.
• Expert knowledge and understanding of US Healthcare Compliance policies, procedures, and guidelines.
• Expert understanding of related aspects of healthcare regulations (e.g., U.S. federal anti-kickback law, False Claims Act, Sunshine Reporting Requirements, OIG Guidelines for Pharmaceutical Manufacturers, U.S Sentencing Guidelines, AdvaMed Code of Ethics and related regional codes of conduct on interactions with health care professionals, Foreign Corrupt Practices Act, UK Anti-Bribery Act and other related laws, rules, and regulations).
• Technical expertise across all pillars of an effective Compliance program – policies, training, communications, and monitoring
• Strong capabilities in risk management and monitoring that help drive informed decision-making and enable the business to operate with integrity, accountability, and sustainabl