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 Policy & Process Improvement 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 pharmaceutical/medical device/life sciences industry is preferred.
Main Objective:
The Lead, Compliance Policy & Process Improvement oversees all ongoing activities related to the development and execution of a company-wide policies and procedures for Arthrex employees and third parties. Specifically, this position is accountable for documentation of the Global Risk Management & Compliance (RM&C) Program and continuous process improvement of the RM&C Program and compliance controls within business process.
Essential Duties and Responsibilities:
Lead the design, development, and implementation of compliance 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 compliance-related policies and ensure global principles and best practices are shared and adopted across geographies and functions.
Develop a framework and guidance for promulgating, updating, 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, 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.
Lead the company’s approach to regional and local policies with an eye towards promoting efficiency and consistency while allowing for appropriate local flexibility.
Partners closely with Global Compliance Training & Communication colleagues to ensure appropriate holistic approach to policies, education, and communication.
Work with Audit, Legal, RCOs and HR on special projects that arise as a result of 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 standards; 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 a policy platform. Consistently analyze processes, track best practices, and provide recommendations and insight to increase efficiency and effectiveness of processes, systems, and technology.
Develop strong relationships throughout multiple businesses and regions to foster a consistent and collaborative approach to proactive compliance.
Foster a continuous improvement mindset and proposes enhancements to the program informed by industry trends and best practices.
Supports other RM&C department projects, as assigned.
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; preferably in Business, Healthcare or related field
Minimum 3 years of experience working in a complex healthcare or business organization preferred
Minimum 3 years of experience in Legal, Compliance, or Risk Management required
Direct experience with policy writing and/or maintenance required
Experience within the healthcare/life sciences/biotech industry preferred
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong analytical, problem solving, and communication skills required, including a thorough understanding of how to interpret business needs and translate them into tangible documents and/or deliverables
Detail oriented and have overall solid business acumen
Ability to work independently and as part of a team. Ability to manage multiple projects/assignments concurrently.
Build collaboration by encouraging trust, mutual respect, and shared purpose among team members.
Ability to understand and develop business process and controls.
Comfortable working in situations with no clear answer.
Ability to prioritize projects and responsibilities.
Ability to adapt in a dynamic and high-growth environment.
Knowledge and clear understanding of the required elements of effective Compliance programs and experience with AdvaMed code and other relevant standards.
Machine, Tools, and/or Equipment Skills:
Intermediate (or better) level of proficiency in MS Excel, MS Word, and PowerPoint.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to understand strategic priorities and apply risk-based considerations to factual analysis.
Language and Communication Skills:
Must demonstrate strong written and verbal communication skills. Must demonstrate an ability to interact well at all organization levels and collaborate with a team.
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.
