Director of Compliance and Quality

Director of Compliance and Quality About the Role: MED-EL Corporation, located in Research Triangle Park and headquartered in Austria, is a worldwide leader in hearing implant research and technology and is committed to designing and manufacturing advanced hearing systems.
We offer competitive salaries and benefits.
The Director of Compliance and Quality is to establish and maintain dialogue with the executive team and other stakeholders to effectively communicate, guide and coach on compliance program developments.
It is responsible to promote with stakeholders a proactive approach to Compliance that is focused on partnerships, prevention, and risk mitigation.
RESPONSIBILITIES Provide guidance and education on complex Compliance issues related to payor relationships, distribution, coverage and reimbursement, state pricing transparency, field reimbursement activities and services.
Direct risk management activities within the company pertaining to regulatory and legal requirements for healthcare providers and businesses in the US (federal, state and local laws and regulations - trade law, FDA, FTC, OIG/DOJ) Serve as MED-EL's Corporate Compliance Officer and head of MED-EL's Corporate Compliance Committee, directing activities necessary to ensure compliance with regulatory requirements of a medical device company.
Acts as the official MED-EL Corporation correspondent to the FDA.
Liaise with HQ Head of Legal on matters presenting significant risk (legal claims, enforcement actions, etc.
).
Assist with development of Company Policy, Procedures and Guidance Documents as needed, following established document control and document distribution procedures.
Provide day-to-day leadership, guidance, and coaching to the QA/ Compliance staff and coordinate with Headquarter staff as appropriate Coordinate activities necessary for company compliance with areas regulated by the OIG/DOJ and coordinate response to any government inquiries/investigations.
Serve on MED-EL's respective Management Review Committees: Regulatory Affairs/Quality Assurance/Product Management team, Product Policy Team, Safety Review Committee, and serve as a resource to company Grants Committee, Medical Advisory Group, Product Management Team, Import/Export Compliance Team, Corrective and Preventative Action Board, ICDC & Business Continuity Team.
Serve on Internal Audit team, conducting formal (scheduled) and informal audits, intended to identify areas of risk and provide continual improvement.
Conduct company investigations, as needed, at the request of Executive Management or in response to compliance concerns.
Identify and respond to compliance issues and questions in a thoughtful, solutions-oriented and timely manner, in alignment with Compliance best practices REQUIREMENTS Bachelor’s degree in business, finance, life sciences, or healthcare 10 years of market access, compliance, and/or related experience with a bachelor's degree or 7 years of market access, compliance, and/or related experience with a JD preferred Related experience working in the life sciences industry (pharmaceutical, biotech, medical device, etc.
) Management experience required Ability to build and maintain professional relationships with stakeholders Demonstrated knowledge of regulatory/compliance requirements, including Anti-Kickback Statute, False Claims Act, government pricing regulations, and state price transparency laws and regulations Strong communication skills, including creating and delivering presentations to various audiences Critical thinking, analytical and problem-solving skills Strong attention to detail **A COVID-19 Vaccination is required to become a MED-EL Team Member.
Maintaining a healthy, virus‐free workforce will enable us to continue to carry out the important mission of our Company.
Proof of your COVID-19 Vaccination will be required prior to your hire date.
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