Complaint/MDR Systems Manager - (Job Number: 0810004)

Complaint/MDR Systems Manager - (Job Number: 0810004) Description Analyze and investigate complaint information to ensure complaints are adequately addressed in a timely and accurate manner. Maintain and continually improve the complaint/MDR system to ensure that problems reported are recorded and investigated promptly, reports required by FDA regulations are filed within the prescribed time limits, and issues identified are addressed through coordination with the appropriate business functions. Supervise associates responsible for same. BS degree in Engineering, related science, or equivalent. Minimum 3 years experience managing people in a regulated environment. Ability to write technical reports as related to Health Hazard Evaluations, Journal Articles or White Papers. Experience in orthopedics is an asset in this role. Additional assets include mechanical skills, medical device reporting regulation experience, orthopedic sales experience, blueprint reading and interpretation of specifications, above average communication skills and product complaint experience. Expertise with FDA regulations for medical devices as they relate to product complaints && MDR reporting is also an asset. Broad knowledge of medical device industry is a plus for this position. Proficiency with computers. Above average interpersonal skills is required for this position.. Apply Now