Analyst II, Postmarket Surveillance
Minneapolis, MN 55442 | 12 Months
Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding information needed specific to product complaints (e.G. physicians, hospital personnel, sales representatives, international offices), independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA) and submits reports within required timeframe, diligent of any unusual trends in product complaints and communicates them with mgmt., complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments, Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors. Performs other related duties and responsibilities as assigned.
•Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work • Knowledge of global regulations for medical device reporting and medical terminology is a plus• Strong written and oral communication skills are required• Good problem-solving and proficient computer skills are required• Ability to work within a team and as an individual contributor in a fast-paced, changing environment• Effectively multitasks, prioritizes and meets timelines• Strong organizational and follow-up skills, as well as attention to detail• Ability to maintain regular and predictable attendance.