Arthrex – Regulatory Affairs Specialist II – Naples, FL

Job title: Regulatory Affairs Specialist II Company: Arthrex Job description: Requisition ID: 56221 Title: Regulatory Affairs Specialist II Division: Arthrex, Inc. (US01) Location: Naples, FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Regulatory Affairs Specialist II who will be responsible for managing product activities related to regulatory submissions and registration for assigned product development initiatives. The RAS II will manage the RA activities by setting priorities and providing guidance and development to junior Specialists. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™. 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. Generous relocation package offered! Full-time remote option available for candidates with demonstrated experience effectively WFH. Regulatory Affairs Senior Specialist Duties and Responsibilities:

• Develop U.S. and Canada regulatory strategy and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
• Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable.
• Advise and provide regulatory direction to assigned Product Development Team(s) on the regulatory requirements, documentation and testing needed for FDA & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
• Prepare, write, and submit FDA and Health Canada submissions for new products and product changes as required in accordance with established time-lines and submission dates to ensure timely approvals while in compliance with regulations.
• Partner with Regulatory Affairs International Divisions staff to provide regulatory support for new products and changes to existing products.
• Provide business and product information to Regulatory Affairs International Divisions staff to enable development of strategies and communicate that information to assigned Product Development Team(s).
• Review and approve all design control documentation, 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 Product Development Team(s) to resolve (potential) 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.
• Interact directly with FDA and/or Health Canada on projects/products at reviewer level.
• Establish, develop and maintain positive relationships with regulatory agency personnel.
• Maintain proficiency in applicable regulatory requirements. Education/Experience
• 2 years relevant experience required preferably in a regulatory affairs role in the life science industry.
• Bachelor's degree required, engineering or science discipline preferred. Advanced degree preferred.
• Orthopedic medical device experience preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional area.
• Experience reviewing product labeling and advertising/promotional material for medical devices.
• Clinical or statistical experience 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. 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. 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. Expected salary: Location: Naples, FL Apply for the job now! Apply tot his job

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