Regulatory Affairs Specialists

Job description

Requisition ID: 65504 Title: Regulatory Affairs Specialists 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 Regulatory Affairs Specialists for our Global Headquarters in Naples, Florida. RA Specialists are responsible for managing specific aspects of the Arthrex Regulatory Affairs program with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. RA Specialists play a critical role in regulatory approval efforts. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better Essential Duties and Responsibilities: - 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. - May 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, or clinical study complia...