Analyst II, Postmarket Surveillance

Abbott Laboratories • Plano, TX

1d • $61,300 - $122,700 • Onsite

About The Position

This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Under the guidance of management, the Postmarket Surveillance Analyst II is responsible for leading and executing complaint handling and investigation activities. This role oversees the end-to-end management of global product complaints, including intake, documentation, and thorough investigation of reported events across a diverse product portfolio. The Analyst ensures accurate and timely data entry into complaint management systems, independently assesses reportability, and submits required medical device reports to regulatory authorities in compliance with applicable regulations.

Requirements

• Associate’s Degree 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

Nice To Haves

• Bachelor’s Degree preferably in healthcare, science, or technical fields
• Equivalent combination of education and work experience

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.
• 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.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree