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Manager - Compliance - North America at Arthrex, Inc. in Naples, Florida

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:


















Requisition ID: 50138 
Title: Manager - Compliance - North America 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

Arthrex is a global medical device company and leader in orthopedics medical education. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Risk Management & Compliance department is based in Naples, Florida and includes a team of varied compliance, risk management, audit and legal professionals. Arthrex is actively searching for a North America Compliance Manager to join the Risk Management & Compliance team. The successful candidate will manage and further enhance the Company’s North America compliance program, including working with our Agencies to develop and managing their own programs. Experience with U.S. anticorruption laws in the pharmaceutical, medical device, or life sciences industries is preferred.

Main Objective:

The Compliance Manager - North America will provide 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 highly visible role will be responsible for leading all aspects of the agency 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, Arthrex internal compliance policies, developing and delivering Arthrex internal and agency-specific compliance trainings, and implementing and advising on compliance controls across the business and at the agency level.

Essential Duties and Responsibilities:


  • 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.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

Bachelor’s degree required; J.D., other advanced degree or professional license/certification (e.g., CCEP, CPA, CIA, etc.) strongly preferred.

5 years' experience in Legal, Compliance, Risk, or Internal Audit required; preferably within the healthcare/life sciences/biotech industry.

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.

  • Demonstrated ability to lead and influence in a large, matrixed organization—particularly in situations with no authority.

  • Ability to adapt in a dynamic and high-growth environment.

  • Exceptional written, verbal, analytical, organizational, problem solving and presentation 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.

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

 





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