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Sr. Specialist, Regulatory Affairs

2 months ago

Naples, United States Arthrex Full time

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Title:

Sr. Specialist, Regulatory Affairs - EU MDR 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. 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 Regulatory Affairs management, 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 is based out of the Arthrex headquarters in Naples, Florida. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better. We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy. Generous relocation package offered Duties and Responsibilities: Creates/updates technical documentation to achieve and maintain 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. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of writings, technical instructions in mathematical or diagram form, communications, and deal with several abstract and concrete variables. Mathematical Skills Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free Onsite Medical Clinics Free Onsite Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Time Off Employee Assistance Provider (EAP) 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.

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