Postmarket Surveillance Analyst II

Main Purpose of the Role Under the direction of management, the Postmarket Surveillance Analyst may perform two different functions within complaint handling. The first function is complaint investigation management, which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical device reports with various regulatory agencies; participating on cross‑functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering). The second function is performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro‑mechanical medical devices and systems), such as performing non‑destructive and destructive testing; reviewing device history records; coordinating product testing/analysis with other departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the Postmarket Surveillance Laboratory equipment. Main Responsibilities Initiate and manage the complaint file, maintaining accurate entry of complaints in the database. Communicate verbally and in writing internally and externally to field representatives regarding information needed specific to product complaints, maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Perform other related duties and responsibilities, as assigned. Independently perform investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints; independently assess 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 send reports within required time frames, consulting as needed with management. Prepare customer letters with investigation findings; be diligent of any unusual trends in product complaints and communicate them to management. Participate 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); archive complaint records and retrieve information on closed investigations. Ensure 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. Support the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements; comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Perform product evaluations in a timely manner; execute evaluations to develop a well‑documented and accurate root‑cause evaluation; coordinate evaluations with other departments and external consultants; use procedures, judgment, and experience to determine appropriate testing of returned products with minimal guidance; review all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations); interpret/review technical product specifications, measurements, and device history records; prepare technical reports of findings and enter them into the complaint system; review external vendor/consultant evaluations and enter them into the complaint system. Be diligent of any unusual trends in product evaluations and inform management; independently assess the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findings. Adhere to the device retention and disposal procedures. Collaborate independently with other team members and departments needing product evaluation information; determine when additional support may be needed from other teams based on evaluation findings (e.g. potential manufacturing‑related issues); train new employees to the product evaluation process. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Work environment varies from well‑lit 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. Perform tasks that regularly require good corrective vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees. Education Associate’s Degree (±13 years) plus 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work. Or an equivalent combination of education and work experience. Bachelor’s Degree (±16 years) preferably in the healthcare, science, or technical fields, or an equivalent combination of education and work experience. Experience / Background Knowledge of global regulations for medical device reporting and medical terminology is a plus. Strong written and oral communication skills are required. Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously. Good problem‑solving and proficient computer skills are required. Experience working in a broader enterprise/cross‑division business unit model preferred; ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment; ability to leverage and/or engage others to accomplish projects. Multitasks, prioritizes, and meets deadlines in a timely manner. Strong organizational and follow‑up skills, as well as attention to detail. Ability to travel approximately 10%, including internationally. Ability to maintain regular and predictable attendance. The base pay for this position is $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr Abbott