Product Surveillance Clinical MDR Specialist I (Remote)

Requisition ID: 63304 Title: Product Surveillance Clinical MDR Specialist I (Remote) Division: reputed company, Inc. (US01) Location: Remote Salary Range: Salary Minimum: 68,500 Salary Maximum: 94,750 reputed company, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. reputed company 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 reputed company 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 reputed company™. 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 reputed company 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 reputed company company personnel to evaluate and investigate customer complaints and adverse event reports.
• Closes complaint files in accordance with regulation and reputed company standards.
• Prepares closing letters to complainants, medical facilities, distributors, and other reporters.
• Maintains reputed company knowledge of industry regulations and procedures reputed company to job function.
• Monitor the FDA’s MAUDE website for potential product complaints reputed company to reputed company 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 reputed company field.
• Experience working in the medical device or drug/pharma industry with adverse event reporting responsibility preferred.

Knowledge and reputed company 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 reputed company, 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 reputed company the job based upon job requirements. Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to reputed company the job based upon the job requirements listed above. Ability to verbally communicate reputed company and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. reputed company 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)

reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national reputed company, disability, protected veteran status, or any other status protected by law. Apply tot his job Apply To this Job