Product Surveillance Clinical MDR Specialist

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 Product Surveillance Clinical MDR Specialist who is responsible for evaluating and investigating complaints involving potential or existing adverse events associated with the use of Arthrex medical device products. The Product Surveillance Clinical MDR Specialist also assists with researching, compiling, and submitting regulatory reports to United States and International regulatory agencies in accordance with applicable regulations. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This position is eligible for remote work.

Essential Duties and Responsibilities:

• Responsible for evaluation of complaints with respect to United States and International adverse event reporting regulations.
• Performs submission of adverse event reports to United States and International regulatory agencies.
• Meets deadlines for closures of complaints and adverse events as assigned.
• Examines records related to adverse event reporting such as medical reports, hospital evaluations, operative reports, and other medical and surgical reports as needed.
• Corresponds with customers, medical professionals, legal departments, and various Arthrex company personnel to evaluate and investigate customer complaints and adverse event reports.
• Closes complaint files in accordance with regulation and Arthrex standards.
• Prepares closing letters to complainants, medical facilities, distributors, and other reporters.
• Maintains current knowledge of industry regulations and procedures related to job function.
• Monitor the FDA’s MAUDE website for potential product complaints related to Arthrex products.
• Participates in FDA and ISO audits as required.

Education and Experience:

Bachelor’s degree required in Health Sciences, Biomedical Engineering, Nursing, Risk Management or related field.

Experience working in the medical device or drug/pharma industry with adverse event reporting responsibility preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Knowledge of FDA 21 CFR 820, cGMP, and ISO13485:2016, EU MDR, MDSAP, and regulations from around the world

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents 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
• Gym Reimbursement Program
• 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.