Requisition ID: 60233 Title: Regulatory Affairs Specialist I (Asia-Pacific) Medical Devices Division: Arthrex, Inc. (US01) Location: Naples, FL

Arthrex, Inc. is a world leader in orthopedic medical device innovation and education, dedicated to its mission of Helping Surgeons Treat Their Patients Better™. We are currently seeking a motivated International Regulatory Affairs Specialist I to join our collaborative team at our headquarters in Naples, Florida. In this crucial role, you will facilitate the registration of cutting-edge medical devices across the Asia Pacific (APAC) region, playing a key part in delivering superior orthopedic solutions to this dynamic and expanding market. At Arthrex, your efforts will directly enhance patient care and medical practices globally, providing you with a profoundly fulfilling professional journey. We offer a collaborative workplace environment where your contributions have a worldwide impact. Enjoy comprehensive benefits, including relocation support, in a company that values and actively supports its employees in making a difference.

We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy. Relocation assistance offered. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better ™.

Duties and Responsibilities:

• Coordinates and collects specific registration information with Engineering, R&D, Manufacturing, Quality Assurance, and other applicable departments as necessary to support device registration requirements in APAC.


• Assembles technical information to create device registration dossiers.


• Manage document and registration requests from in-country Arthrex subsidiaries.


• Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.


• Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable.


• Partner with in-country Regulatory Affairs teams to provide regulatory support for changes to existing products.


• Review engineering change requests for design, manufacturing and labeling changes, and customs requests to ensure compliance with global regulations.


• Provide feedback and on-going support to the global Regulatory Affairs team to resolve regulatory issues and questions from regulatory agencies.


• Rigorously review regulatory documentation to ensure completeness, clarity, consistency, and conformance to regulations and guidelines.


• Coordinate and consult with manager and/or other departments on the content and review of regulatory documentation.


• Provide support to currently-marketed products as necessary. This includes: reviewing labeling; reviewing promotional material; reviewing product changes; preparing documentation for changes requiring government approval; and preparing submissions and reports for regulatory agencies as required by product status.


• Schedule and accommodate meetings and deadlines for the APAC time zones so all team members can participate.

Requirements:

• Bachelor's degree required.


• Experience in a regulatory affairs role in the life science industry preferred.


• Experience authoring and submitting medical device registrations/licenses/submissions in the APAC region preferred.

Reasoning Ability : Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making.

Machine, Tools, and/or Equipment Skills: Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Ability to understand and respect the diverse cultural backgrounds, practices, and norms of team members, including being aware of cultural nuances that may influence communication styles and business practices.

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.