Postmarket Surveillance Analyst II

Responsibilities

• Manage complaint investigations, including receiving reports, entering data into databases, and filing medical device reports with global regulatory agencies.
• Perform product evaluations on returned medical devices using non-destructive and destructive testing to determine root causes.
• Prepare detailed technical reports of evaluation findings and communicate results to internal teams and external customers.
• Collaborate with cross-functional teams, including Regulatory, Quality Engineering, and Legal, to support risk management and product safety.
• Maintain accurate department procedures, work instructions, and training for new employees.
• Monitor and communicate unusual trends in product complaints or evaluations to management.

Requirements

• Associates Degree plus 10 years of relevant experience in complaint handling, medical device reporting, or product evaluation.
• Or, a Bachelor's Degree (preferably in healthcare, science, or technical fields) plus 6 years of relevant experience.
• Strong knowledge of medical device reporting and global regulatory requirements.
• Excellent technical report writing and verbal communication skills.
• Proven problem-solving skills and the ability to manage multiple investigations simultaneously in a fast-paced environment.
• Proficiency with computer systems and the ability to travel approximately 10%.

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 the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. With over 115,000 colleagues, we serve people in more than 160 countries.