Postmarket Surveillance Analyst - Regulatory & Product Review

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

Benefits offered by this job

Career development

Health coverage

Retirement savings plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a Postmarket Surveillance Analyst to manage complaint investigations and product evaluations for a broad range of medical devices. The role involves regulatory reporting, data entry, and coordination with Regulatory, Quality Engineering, and other teams.

You will perform product evaluations, prepare technical findings, and maintain compliant documentation while supporting QMS/EMS activities and ensuring timely regulatory filings.

Qualifications

• Associate’s degree or equivalent education and work experience.
• Experience supporting complaint handling investigations, medical device reporting, product evaluation.
• Knowledge of global regulations for medical device reporting is a plus.
• Strong written and oral communication skills.
• Ability to work independently and on teams in a busy department.
• Ability to travel ~10%, including internationally.

Responsibilities

• Review complaints for regulatory compliance, reportability, and patient safety impact.
• Communicate with field representatives and internal teams about product complaints.
• Conduct investigations with customers or field staff with minimal direction.
• Prepare customer letters with investigation findings.
• Collaborate in cross-functional complaint review groups and maintain records.
• Support QMS, EMS, and regulatory requirements.

Skills

Strong communication

Independent worker

Team collaboration

Travel readiness

Education

Associate’s degree or equivalent

Bachelor’s degree preferred

Job description

Abbott is seeking a Postmarket Surveillance Analyst to manage complaint investigations and product evaluations for a broad range of medical devices. The role involves regulatory reporting, data entry, and coordination with Regulatory, Quality Engineering, and other teams.

You will perform product evaluations, prepare technical findings, and maintain compliant documentation while supporting QMS/EMS activities and ensuring timely regulatory filings.