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.
• Participate in cross-functional teams, including risk management and new product development meetings.
• Maintain accurate department procedures, work instructions, and training for new employees.
• Ensure compliance with FDA regulations, Quality Management Systems (QMS), and Environmental Management Systems (EMS).

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 abilities and proficiency with computer systems.
• Ability to travel approximately 10%, including international travel.

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.