Manager - Compliance North America

* This position is based in Naples, FL. Open to remote for the right candidate. If remote, travel to HQ required quarterly*

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Manager of Compliance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

The Compliance Manager—North America will provide strategic guidance to North American agencies, Regional Sales Directors, and Managers, as well as to key North American stakeholders across the region, regarding the conduct of business in accordance with laws (e.g., the Anti-Kickback Statute), industry codes, and Arthrex policies. This highly visible role will be responsible for leading all aspects of the agency's field compliance program and for managing compliance program processes and projects throughout the North American region.

Specifically , this position is accountable for developing and implementing the agency field compliance program and Arthrex internal compliance policies, developing and delivering Arthrex internal and agency-specific compliance training, and implementing and advising on compliance controls across the business and at the agency level.

• Provides strategic insight and guidance to all North American agencies and for the overall field compliance program.
• Manages all aspects of the North America field compliance program; supports the management of the North America Compliance team and all elements of the North America compliance program, including conducting risk assessment(s), implementing and training on relevant policies & procedures, and assisting with investigations to provide risk-based guidance and support.
• Understands business strategy and designs and implements pragmatic controls to manage compliance risk.
• Provides strategic input to both North America and Global compliance initiatives.
• Drafts, implements, and maintains compliance policies, procedures and other guidance documents.
• Assists the business in system implementation, sharing of best practices, and in the development of tools to support responsible business practices.
• Provides timely and thoughtful guidance to business stakeholders at all levels of the organization as well as to Arthrex external agencies regarding regulations, trade associations, and policy and procedure interpretation.
• Partners with business stakeholders at all levels of the organization to determine gaps or areas of improvement for compliance support.
• Contributes to the global investigations program and supports compliance investigation procedures both internally and within the agency field compliance program.
• Provides support to the training and communications team through the development and creation of relevant compliance training materials and content as well as providing support with audience identification and training completion tracking.
• Supports risk assessment, Arthrex internal and external agency auditing, monitoring and other Compliance department activities.
• Assists with audit remediation by working with the business and key stakeholders to implement recommended areas of improvement.
• Utilizes influencing and interpersonal skills to help gain buy-in from key internal Arthrex and external agency stakeholders for new or changing internal compliance and external field compliance program initiatives.
• Builds and maintains strong working relationships across all functions and levels of the organization.
• Leads other Compliance department projects and initiatives, as assigned.
• Up to 20% travel may be required.
• Ensure compliance within the functional area and support the compliance objectives of the organization as a whole.

• In-depth understanding of:
• U.S. healthcare compliance laws and regulations (e.g., FCA, AKS, Stark Law, FCPA).
• Industry codes such as Adva Med.
• Business processes, internal controls, and compliance frameworks.
• Familiarity with:
• Compliance program development and implementation.
• Risk assessment, auditing, and monitoring practices.
• Global and regional…