Oversee and manage RTI Surgical’s Global Ethics, Compliance and Risk Management Program to ensure the company's adherence to global laws, regulations and industry codes of conduct.
Ensure that the Global Ethics, Compliance and Risk Management Program complies with U.S. federal and state laws and regulations as well as international laws and regulations.
Maintain practices, policies and procedures to comply with the General Data Protection Regulation (GDPR), Health Insurance Portability and Accountability Act (HIPAA), Foreign Corrupt Practices Act (FCPA), Anti-Kickback Statute (AKS), False Claims Act (FCA), Food, Drug & Cosmetic Act (FDCA), Centers for Medicare & Medicaid Services (CMS) Open Payments program, U.S. Sentencing Commission Guidelines, Office of Inspector General (OIG) Guidance Documents, MedTech Europe Code of Ethical Business Practice, AdvaMed Code of Ethics on Interactions with Health Care Professionals and the company’s Code of Conduct.
Train employees and distributors on compliance policies and procedures.
Provide guidance on sales training and promotional materials to ensure compliance with applicable laws and regulations, including the FDCA and Lanham Act, and the applicable laws and regulations of the Federal Trade Commission.
Conduct auditing and monitoring as needed, including performing due diligence on health care providers and distributors.
File annual Physician PaymentsSunshine Act reports, as well as other required U.S. and international reports, including reports for Vermont, Massachusetts and Belgium.
Manage compliance hotline and conduct internal compliance investigations.
Provide guidance on supply chain and export control laws and regulations applicable to a surgical implant company, including but not limited to, Made in the USA and Federal Acquisition Regulations.
Provide guidance on discounts and rebate agreements with group purchasing organizations, health systems and distributors.
Communicate with all internal stakeholders to ensure that the company’s strategies and operations are conducted in an ethical and compliant manner.
Provide regular reports to RTI’s Board of Directors, Senior Leadership Team and Corporate Compliance Committee.
EDUCATION / EXPERIENCE REQUIRED AND / OR PREFERRED:
Bachelor of Science or Bachelor of Arts degree in healthcare, business, law or related field required. JD preferred.
5+ years’ professional experience in healthcare, medical device or drug manufacturer risk management and compliance required.