Director, Ethics and Compliance

Job Description: • Oversee and evolve the ethics & compliance function and collaborate with key stakeholders to ensure compliance with applicable laws and regulations covering topics such as anti-kickback statute, global anti-bribery/anti-corruption (ABAC), antitrust, data protection and privacy, conflicts of interest, transparency, interactions with healthcare professionals and entities including fee-for-service engagements, third party risk management, advertising and promotion of medical devices, sponsorships, grants, donations, samples. • Collaborate with Commercial team members to create solutions for developing and maintaining compliant relationships with healthcare professionals and government officials. • Provide compliance training on a wide range of issues including Worldwide Business Standards (our code of conduct), interactions with healthcare professionals, conflicts of interest, ABAC, labeling and promotional content. • Together with the Chief Ethics & Compliance Officer and other key stakeholders, develop and implement a monitoring and auditing program designed to ensure compliance with internal policies and procedures and applicable laws, regulations and industry guidance and standards. • Review new product offerings to ensure compliance with applicable policies and procedures and laws. • Manage outside counsel as necessary. • Support the implementation of the ethics & compliance risk assessment and mitigation actions as well as monthly compliance reports and executive risk dashboard. • Ensure applicable annual transparency reporting requirements are met (state, federal and international). • Interpret and disseminate information on regulatory and compliance matters. • Assist with internal investigations, business partner and government inquiries and actions, and related responses and resolution. • Enhance corporate compliance and organization reputation by accepting ownership for accomplishing new and different requests, providing prompt and accurate advice and appropriate solution recommendations, and identifying continuous improvement opportunities. • Perform other duties as assigned or as necessity dictates. Requirements: • Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience. • Experience with healthcare law compliance for a global medical device manufacturer (orthopedic medical devices a plus) and experience leading a team or key initiatives. • Strong knowledge of HHS-OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers (including 7+ elements of an effective compliance program). • AdvaMed Code, DOJ’s Evaluation of Corporate Compliance Programs (September 2024), False Claims Act, Anti-kickback Statute, anti-bribery/anti-corruption laws (e.g., FCPA, UK Bribery Act), data protection laws (e.g., GDPR, CCPA), Sunshine Act and other transparency laws. • Experience working with Commercial teams. • Strong understanding of compliance controls, processes and activities common to the medical device industry. • Strong understanding of healthcare compliance and enforcement environment. • Bilingual (English/Spanish) required. Benefits: • Medical, Dental and Vision Coverage • 401K Plan with Company Match • PTO • Paid Parental Leave • Income Protection • Work Life Assistance Program • Flexible Spending Accounts • Educational Benefits • Worldwide Scholarship Program • Volunteer Opportunities Apply Now Apply Now