Analyst II, Postmarket Surveillance

Responsibilities

• Lead and execute end-to-end complaint handling and investigation activities for the Neuromodulation division.
• Manage global product complaint intake, documentation, and thorough investigation of reported events.
• Independently assess reportability and submit required medical device reports to global regulatory agencies (e.g., FDA, European Competent Authorities).
• Communicate findings and information needs to internal and external stakeholders, including physicians, hospital personnel, and field representatives.
• Monitor and communicate unusual trends in product complaints and evaluations to management.
• Participate in cross-functional review groups, including risk management and new product teams.
• Maintain accurate department procedures, work instructions, and training for new employees.
• Support Quality Management Systems (QMS) and ensure compliance with FDA and other regulatory requirements.

Requirements

• Associate’s Degree plus 10 years of relevant experience supporting complaint handling investigations, medical device reporting, or product evaluation.
• Equivalent combination of education and work experience.
• Proven experience in complaint handling investigations and medical device reporting.
• Experience with product evaluation and technical investigations.

Preferred Qualifications

• Bachelor’s Degree, preferably in healthcare, science, or technical fields.

Benefits

• Career development opportunities within an international healthcare leader.
• Health Investment Plan (HIP) PPO medical coverage options.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement and student debt assistance programs.
• Access to FreeU education benefits for bachelor's degrees.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.