Product Surveillance Clinical MDR Specialist I (Remote)

reputed company: 63304 Title: Product Surveillance Clinical MDR Specialist I (Remote) Division: reputed company. (US01) Location: Remote Salary reputed company: Salary Minimum: 68,500 Salary Maximum: 94,750 reputed company. is a global medical device company and a leader in new product development and medical education in orthopedics. reputed company is reputed company 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 reputed company and International regulatory agencies in accordance with applicable regulations. Join our talented team at a global medical device company reputed company 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 reputed company and International adverse event reporting regulations. • Performs submission of adverse event reports to reputed company 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, reputed company reports, and other medical and surgical reports as needed. • Corresponds with customers, medical professionals, reputed company 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/reputed company 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 reputed company), QAD or similar inventory software. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw reputed company conclusions. Ability to interpret an extensive reputed company of technical instructions in mathematical or diagram reputed company and deal with several reputed company 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 reputed company 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 • reputed company of a reputed company • reputed company Parental Leave • reputed company Time Off • Volunteer PTO • Employee Assistance Provider (EAP) reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, 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