Team Lead, Regulatory Affairs - Arthroplasty Product Development

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 Team Lead of Regulatory Affairs.  The Regulatory Affairs Team Lead is responsible for supervising the daily operations of a business unit’s Regulatory Affairs team to ensure strategic regulatory strategy, timely regulatory submission preparation, and the completion of regulatory deliverables throughout the product development process in compliance with all applicable regulations and guidance for the commercial distribution of products within US and Canada.  This position will play a critical role in regulatory approval efforts with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient and compliant manner.  In addition, the Team Lead will manage the Regulatory Affairs activities of the assigned product development team(s) by setting priorities and providing guidance and development to direct reports.  Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This position is based out of the Arthrex headquarters in Naples, Florida. Relocation assistance may be available along with Arthrex’s exceptional employee benefits and work culture.

Duties and Responsibilities:

• Plan, coordinate, and manage regulatory affairs activities for all product development and maintenance projects to meet deadlines for assigned business unit.
• Provide direction, leadership and coaching to staff to meet schedules and resolve technical or operational problems.
• Independently perform, as well as instruct and monitor the work of direct reports for the regulatory duties and responsibilities listed below:
  • Develop regulatory strategies 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 project teams on premarket regulatory requirements, such as documentation and testing needed, labeling requirements, and/or clinical study compliance issues.
  • Coordinate, prepare, write, submit and review regulatory submissions for projects in accordance with established product launch or other applicable timelines.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
  • Review and approve design control documentation, engineering change requests, manufacturing and labeling changes, and other applicable requests for adherence to global regulatory compliance.
  • Review and approve product promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies.
  • Communicate with regulatory agencies with or without direction regarding pre-submission strategies, potential regulatory pathways, testing requirements, or clarification and follow-up of submissions under review.

Requirements:

• Bachelor’s Degree required, preferably in Life Sciences or Engineering.
• Advanced Degree (MS, MBA) preferred.
• Regulatory Affairs (RAC) preferred.
• 7 years direct experience in a Medical Device Regulatory Affairs role required.
• Prior successful experience in Regulatory Affairs supervisory role preferred.
• Experience in orthopedic medical device industry preferred.
• Experience in independently preparing regulatory documentation required.
• Experience with US and EU regulatory agencies submission process and regulatory strategy for medical devices required.
• Experience in providing strategic advice on integrated regulatory development plans and executing regulatory deliverables for product development required.
• Experience in determining appropriate regulatory requirements for new products and product changes required.
• Experience in reviewing and approving product labels and promotional/advertising materials required.

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.