RequisitionID: | 63590 | ||||
Title: | Compliance Policy & Process Lead | ||||
Division: | Arthrex, Inc. (US01) | ||||
Location: | Remote | ||||
Salary Range: |
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**This position is based in Naples, FL. Remote optional for the right candidate. If remote, travel required to Naples headquarters quarterly for 1 week**
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 Compliance Policy & Process Lead to join the Risk Management & Compliance team. The successful candidate will manage and develop compliance policies and procedures across the global organization, as well as drive efforts to operationalize compliance principles and controls in business activities to ensure compliance with relevant laws, regulations and standards. Experience in policy writing/development and working in the healthcare, life sciences, or biotech industry is preferred.
Main Objective:
The Lead, Compliance Policy & Process, administers all ongoing activities related to the development and execution of non-QMS company-wide policies and procedures for Arthrex employees and third parties. This position reports into the Manager, Global Compliance Policy, Training & Communications Specifically, this position is accountable for documenting the Global Risk Management & Compliance (RM&C) Program, continuous process improvement of the RM&C Program, and documenting compliance controls within the business process.
Essential Duties and Responsibilities:
- Lead the design, development and implementation of non-QMS policies and procedures at a company-wide level, in partnership with Legal and RM&C colleagues and relevant business functions.
- Drive global consistency in our approach to non-QMS policies and ensure global principles and best practices are shared and adopted across geographies and functions.
- Develop a framework and guidance for updating, promulgating and operationalizing policies.
- Collaborate with internal, global compliance stakeholders (e.g., Regional Compliance Officers (RCOs), Global Privacy) and other relevant functional areas (e.g., Medical Education or HR) to ensure consistency of compliance controls and requirements as documented in company-wide policies, procedures and other employee and third-party handbooks or manuals.
- Assess and maintain the company’s global compliance policies, addressing any gaps.
- Support the assessment of regional and local compliance policies with an eye towards promoting efficiency and consistency while allowing for appropriate local flexibility.
- Partners closely with Global Compliance Policy, Training & Communication colleagues to ensure an appropriate holistic approach to policies, education and communication.
- Work with Audit, Legal, RCOs, and HR on special projects that arise from investigations or audit findings, and where the need for remediation or process re-engineering is identified. Work with the various business functional areas to implement change management/training plans to get new policies and/or processes adopted quickly and successfully.
- Develops and maintains deep knowledge regarding applicable laws, regulations, and industry codes; applies knowledge to drive continuous improvement of compliance policies and procedures.
- Provide input on modifications to the compliance program to reflect changes, clarifications, or updates in applicable law, regulations, policy, and business strategy.
- Drives innovation to increase accessibility to compliance policies and standards and supports company efforts to implement and manage a policy platform. Consistently analyze processes, track best practices, and provide recommendations to increase process and system effectiveness.
- Develop strong relationships throughout multiple businesses and regions to foster a consistent and collaborative approach to proactive compliance.
- Foster a continuous improvement mindset and propose enhancements to the program informed by industry trends and best practices.
- Supports compliance training and communications projects as assigned.
- Supports other RM&C department projects as assigned.
Education/ Experience:
- Bachelor’s degree required (preferably in Business, Healthcare, or related field).
- Minimum 5 years of experience in Legal, Compliance or Risk Management is required.
- Experience in policy writing and maintenance is required.
- Background in healthcare, life sciences, or biotech industry preferred.
- Minimum 5 years of experience working in a complex healthcare or business organization preferred.
Knowledge and Skills:
- Deep understanding of compliance program elements, including policy development and process improvement.
- Familiarity with the AdvaMed Code and other healthcare/life sciences industry standards.
- Knowledge of applicable laws, regulations, industry codes and best practices.
- Understanding business processes, internal controls and change management strategies.
- Awareness of policy platforms and tools to enhance accessibility and compliance engagement.
- Strong analytical, problem-solving, and communication skills.
- Excellent written and verbal communication across all organizational levels.
- Ability to manage multiple projects and work both independently and collaboratively.
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
- Skilled in building trust and fostering collaboration across global teams.
Machine, Tools, and/or Equipment Skills:
Intermediate (or better) level of proficiency in MS Excel, MS Word, and PowerPoint.
Arthrex 2023 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
- Gym Reimbursement Program
- 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 or protected veteran status.
Job title: Compliance Policy & Process Lead
Naples, FL, US, 34108
Nearest Major Market: Naples
Job Segment:
Business Process, Medical Device, Orthopedic, Change Management, Engineer, Management, Healthcare, Engineering