Senior Specialist, Regulatory Affairs (Remote)

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Specialist of Regulatory Affairs for its Extremities & Trauma product development team. The Senior Specialist is responsible for managing market access activities and 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.

This position can be remote or based out of the Arthrex headquarters in Naples, Florida. Relocation assistance may be available along with Arthrex’s exceptional employee benefits and work culture. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Regulatory Affairs Senior Specialist Duties and Responsibilities:

• Serve as the Regulatory Affairs subject matter expert for assigned new product development projects and product change projects.
• Develop US/Canada regulatory strategy for assigned projects.
• Evaluate the risk between different regulatory strategies and determine the best strategy and offer mitigation strategies to best meet business objectives for development and change projects.
• Advise and provide regulatory direction to the Extremities & Trauma Product Development team 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 in accordance with established time-lines and submission dates to ensure timely approvals while in compliance with regulations.
• 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 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 by reviewing and approving labeling, promotional material, and product changes and; preparing supporting documentation as appropriate.
• Interact directly with FDA and/or Health Canada on projects/products at reviewer level.
• Establish, develop and maintain positive relationships with regulatory agency personnel.

Education/Experience

• 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.

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.