Senior Specialist, Regulatory Affairs

Arthrex - Naples, FL, US, 34108 Senior Specialist, Regulatory Affairs

Requisition Title: Senior Specialist, Regulatory Affairs 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. We are seeking a Senior Specialist, Regulatory Affairs who will be responsible for managing product activities related to regulatory submissions and registration for Arthrex’s product lines. This position plays a critical role in regulatory approval efforts by developing regulatory strategy, executing regulatory plans, and performing other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices.

Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better.

• Develop U.S., EU 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, EU MDR & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
• Prepare, write, and submit FDA, Notified Body and Health Canada submissions for new products and product changes as required in accordance with established timelines and submission dates to ensure timely approvals while in compliance with regulations.
• Partner with International Regulatory Affairs to provide regulatory support for new products and changes to existing products.
• Provide business and product information to International Regulatory Affairs to enable development of strategies and communicate that information to assigned Product Development Team(s).
• Review and approve design control documentation, engineering change requests for design, manufacturing and labeling changes, and customs requests to ensure compliance with global regulations.
• Provide feedback and ongoing 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 with FDA, Notified Bodies and/or Health Canada on products at reviewer level.
• Establish, develop and maintain positive relationships with regulatory agency personnel.
• Maintain proficiency in applicable regulatory requirements.

• 5+ 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.

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalent if changed by the Company), QAD or similar inventory software.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and…