Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are seeking a Specialist II, Regulatory Affairs (Arthroscopy) who is responsible for supporting product activities related to regulatory submissions and registration for Arthrex’s product lines. This position contributes to regulatory approval efforts by performing activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better.

Duties and Responsibilities:

• Support regulatory strategy and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
• Participate in the review process of 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 as necessary.
• Establish, develop and maintain positive relationships with regulatory agency personnel.
• Maintain proficiency in applicable regulatory requirements.

Education/Experience:

• 2+ years relevant experience required.
• Bachelor’s degree required, engineering or science discipline preferred.  Advanced degree preferred.
• Orthopedic medical device experience preferred.
• Regulatory Affairs Certification (RAC) preferred. 

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalent if changed by the Company), QAD or similar inventory software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form 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.

Arthrex Benefits

• 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 Parental Leave
• Paid Time Off
• Volunteer PTO
• 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, protected veteran status, or any other status protected by law.