Analyst II, Postmarket Surveillance

• Initiates and manages the complaint file. Maintains accurate entry of complaints in the database. 

• Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices).    

•Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. 

• Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management. 

• Prepares customer letters with investigation findings.  Is diligent of any unusual trends in product complaints and communicates them to management. 

Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings). Archives complaint records and retrieves information on closed investigations. 

• Ensures accurate department procedures and work instructions are maintained. Train new employees to the complaint handling process.  Provide support to the Legal Department regarding product complaints. 

• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.  Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 

• Is diligent of any unusual trends in product evaluations and informs management. Independently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings. Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings).  Adheres to the device retention and disposal procedures.  Ensures accurate department procedures and work instructions are maintained. 

• Collaborate independently with other team members and departments needing product evaluation information.  Be able to ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues). Train new employees to the product evaluation process. 

• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 

• Complies with U.S. Food and Drug Administration (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, and vendors.  Performs other related duties and responsibilities, on occasion, as assigned. 

• Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc. 

• Activities require a significant amount of sitting in front of a computer monitor, some standing and walking.  Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.  Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees. 

Required Qualifications

Preferred Qualifications

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