Oversee and manage RTI Surgical’s Corporate Compliance Program, which ensures the company's compliance with all applicable federal, state and local laws and regulations, as well as applicable industry codes of conduct. The Corporate Compliance Officer reports to the company’s Senior Counsel.
Maintain effective internal compliance controls through organization-wide compliance policies and procedures, including but not limited to, policies and procedures related to the General Data Protection Regulation (GDPR), Health Insurance Portability and Accountability Act (HIPAA), Foreign Corrupt Practices Act (FCPA), Anti-Kickback Statute, and company code of conduct, as well as policies and procedures related to data privacy, internal investigations and interactions with health care provider consultants.
Train employees and distributors on compliance policies and procedures.
Conduct internal auditing and monitoring, including performing due diligence on health care providers and distributors and conducting monthly reviews of sales to top distributors and institutions.
File Centers for Medicare & Medicaid Services (CMS) annual reports.
Manage compliance hotline and conduct internal compliance investigations.
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.
5+ years’ professional experience in medical device or drug manufacturer compliance required.
Compliance certifications/credentials preferred.
KNOWLEDGE, SKILLS AND ABILITIES:
Knowledge of applicable global legal and regulatory requirements and how these requirements apply to the organization’s daily operations.
Skills / Abilities:
Conduct investigations and manage the investigations process.
Multi-task, prioritize tasks and work within tight deadlines.
Communicate clearly and effectively and work with various functional divisions of the company such as finance, human resources, marketing and operations.
Use Microsoft Office 365 (Sharepoint, Teams, Excel, Word, PowerPoint, and Outlook).