Postmarket Surveillance Analyst - Product Safety & Compliance

Abbott Laboratories; Burlington (MA); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott is seeking a Postmarket Surveillance Analyst to manage complaint handling and product evaluations. You will investigate incidents, determine regulatory reportability, and file medical device reports as needed.

The role involves cross-functional collaboration, documenting findings, and ensuring timely communication with regulatory bodies and field staff. Responsibilities include maintaining complaint databases, training new staff, and supporting QMS/EMS compliance.

Qualifications

• Associate’s degree or equivalent required; experience in medical device or healthcare industry is a plus.
• Experience supporting complaint investigations, medical device reporting, or product evaluation preferred.
• Strong written and verbal communication skills required.

Responsibilities

• Review and manage product complaints to assess regulatory reporting and patient safety impact.
• Communicate with field personnel and external offices to obtain needed information.
• Lead investigations and evaluate whether FDA/global reports are required.
• Prepare investigation findings letters and track trends in complaints.
• Coordinate with cross-functional teams and maintain accurate records in the database.

Skills

Complaint handling

Regulatory knowledge

Written communication

Team collaboration

Education

Associate’s degree or equivalent

Job description

Abbott is seeking a Postmarket Surveillance Analyst to manage complaint handling and product evaluations. You will investigate incidents, determine regulatory reportability, and file medical device reports as needed.

The role involves cross-functional collaboration, documenting findings, and ensuring timely communication with regulatory bodies and field staff. Responsibilities include maintaining complaint databases, training new staff, and supporting QMS/EMS compliance.