Senior Specialist, Regulatory Affairs - EU MDR (REMOTE OR ONSITE) at Arthrex, Inc. in Naples, Florida

Job Description:

Position Summary:

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.  The Regulatory Affairs Senior Specialist is responsible for supporting MDR device registration efforts in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing products in the most efficient, compliant manner. In coordination with management of Regulatory Affairs, this role will assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations 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™.

Duties and Responsibilities:

• Creates/updates technical documentation to achieve or maintain EU MDD/MDR certification.


• Develops implementation plans for the preparation and submission of new products for the EU market.


• Advises project teams on pre-market regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues.


• Provides project teams with on-going support to resolve any real or perceived regulatory issues.


• Determines the regulatory impact of proposed product changes on EU registrations.


• Coordinate the review of MDR submissions in accordance with established project timelines.


• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.

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.


• Regulatory submission experience with the EU MDR or MDD is required.


• Project management experience is required.


• Exceptional written and oral communication skills required.


• Advanced knowledge of regulatory framework and regulatory requirements for EU MDR.


• Intermediate knowledge of product life-cycle, product development process, design control and change control.

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.