Main Purpose of the Role

Under the direction of management, the Postmarket Surveillance Analyst may perform two different functions within complaint
handling. One role is that of 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 devices 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 other role of the Postmarket Surveillance Analyst 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 of Device History Records; coordinating product testing/analysis with other SJM
departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the
Postmarket Surveillance Laboratory equipment.

Main Responsibilities

• 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.

• Postmarket Surveillance Analyst (product evaluations):Performs product evaluations in a timely manner. Executes product evaluations to develop a well-documented and accurate root cause evaluation. Coordinates product evaluations with other SJM departments and external consultants. Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance. Reviews all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations). Interprets/reviews technical product specifications, measurements and the Device

• History Record. Prepares technical reports of findings and enters them into the complaint system. Reviews external vendor/consultant evaluations and enters them into the complaint system.

• 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.

Qualifications

Education

• Associates 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

• Bachelors 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 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