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 Compliance Specialist, North America. Join our talented team at a global medical device company focused on Helping Surgeon Treat Patients Better.

Main Objective:

The Compliance Specialist will assist Compliance Managers and the Regional Compliance Officer in providing strategic guidance to the North American agencies, Regional Sales Directors, and Managers, as well as to key North America stakeholders across the region, regarding the conduct of business in accordance with laws (e.g., Anti-Kickback Statute), industry codes, and Arthrex policies. This role will be responsible for helping to advance Arthrex’s agency field compliance program by managing compliance program processes and projects throughout the North American region, developing materials for use in the field, and providing compliance advice to North American agencies.

Specifically, this position will assist in the development and implementation of the agency field compliance program, Arthrex internal compliance policies, developing Arthrex internal and agency-specific compliance trainings, and advising on compliance controls across the business and at the agency level.

Essential Duties and Responsibilities:

• Assists in all aspects of the North America field compliance program; supports 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.
• Provides guidance to North American agencies and for the overall field compliance program.
• Understands business strategy and helps to design and implement pragmatic controls to manage compliance risk.
• Provides 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 guidance to business stakeholders and agencies regarding regulations, trade associations, and policy and procedure interpretation.
• Partners with business stakeholders 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.
• Contributes to the field monitoring program through participation in ride-alongs and assisting in records reviews.
• 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 Risk management & Compliance Department activities.
• Assists with audit remediation by working with the business and stakeholders to implement recommended areas of improvement.
• Builds and maintains strong working relationships across all functions and levels of the organization.
• Performs other Risk Management & Compliance Department projects and initiatives, as assigned.
• Up to 20% travel may be required.

Education and Experience:

Bachelor’s degree required. A minimum of 3 years of experience in Legal, Compliance, Risk, or Internal Audit, preferably within the healthcare/life sciences/biotech industry. Advanced degree (such as a JD) can substitute for minimum experience.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Familiarity with laws/regulations applicable to a global healthcare company, including the U.S. Fraud and Abuse laws (e.g., the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (Stark Law)), and the Foreign Corrupt Practices Act.
• Familiarity with medical device industry code and standards for interactions with health care professionals, including Advanced Medical Technology Association (AdvaMed).
• Project management experience and ability to organize and prioritize projects and responsibilities.
• Development and implementation of compliance programs.
• Ability to understand and develop business process and controls.
• Adept at understanding complex concepts and situations presented by the business environment.
• Comfortable working in situations with no clear answer and with limited guidance.
• Ability to adapt in a dynamic and high-growth environment.
• Exceptional written, verbal, analytical, organizational, and problem-solving skills.

Machine, Tools, and/or Equipment Skills:

Intermediate (or better) level of proficiency in MS Excel, MS Word, and MS PowerPoint. Proficient in MS Visio, MS Teams and MS Project.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.