Senior Manager, Regional Compliance, U.S.

Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. 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 Senior Manager, Regional Compliance, U.S. position is a unique career opportunity that could be your next step towards an exciting future.

As a Senior Manager, Regional Compliance, U.S. , you will serve as key business advisor to ensure that employee business practices, particularly employee interactions with health care providers (HCPs) meet Edwards’ high ethical standards.

Workplace Designation: Given the collaborative and complex nature of this work, this role requires being onsite a minimum of 3 days per week at our headquarters in Irvine, CA.

How you will make an impact:

• Leverage subject matter expertise, advise colleagues in multiple divisions on complex ethics matters and HCP interactions
• Serve on educational and research grant review committees
• Develop, design and and conduct instructor-led training
• Advise senior leaders serving on the regional compliance committee
• Manage approval structure for HCP contracts and review non-standard HCP agreements
• Monitor compliance with policies and procedures; develop corrective action plans as needed
• Conduct regional risk assessments
• Track, compile, analyze and use findings to provide key insights to senior leadership
• Interpret internal or external business issues and recommend solutions/best practices
• Proactively search for and drive process improvements, including simplification and streamlining
• Interact with team members and peer managers, taking on leadership roles in cross-functional projects
• Other incidental duties

What you'll need (Required):

• Bachelor's Degree in related field with 10 years of experience OR Master’s Degree with 8 years of experience legal background or experience as an auditor
• Expert knowledge and understanding of healthcare regulations and guidelines (e.g., U.S. federal anti-kickback statute, OIG Guidelines, AdvaMed Code of Ethics on Interactions with Health Care Professionals, other anti-bribery and corruption laws, rules, and regulations); familiarity with ACCME and ICMJE guidelines a plus
• Medical Device or Pharmaceuticals industry experience

What else we look for (Preferred):

• Strong critical thinking and creative problem resolution skills
• Experienced presenter and meeting facilitator
• Excellent organization and time management skills
• Excellent written and verbal communication skills and interpersonal relationship skills
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management
• Ability to manage competing priorities in a fast-paced environment

• Proven successful project management skills
• Experience with business process mapping and developing detailed requirements
• Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) required; experience with J.D. Edwards, Coupa, SharePoint, contracts management software and HCP engagement software a plus

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 $115,000 to $163,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  

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

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries