Postmarket Surveillance Analyst: MDRs & Compliance

Abbott Laboratories; Burlington (MA); On-site; USD 51,000 - 101,000; Full time

Job summary

Abbott in Burlington, MA, is seeking a Regulatory Complaints Analyst within the Heart Failure Division to review customer complaints for regulatory reportability and compliance with GMPs and CFRs.

You will gather data from clinicians, field staff, and labs, draft MDRs and other regulatory reports, and communicate findings to relevant stakeholders. The role emphasizes timely, accurate documentation and cross-functional collaboration.

Qualifications

• Bachelor's degree in biomedical or related field.
• 0-2 years of related work experience.

Responsibilities

• Review complaint communications for regulatory compliance and patient safety impact.
• Develop and modify decision models to uphold regulator-required compliance.
• Gather data from clinical staff, field representatives and labs for investigations.
• Draft regulatory reports (MDRs, MedWatch, Vigilance) and ensure timely submission.
• Collaborate across engineering, lab and internal teams to support investigations.

Skills

Regulatory compliance

Regulatory reporting

Documentation

Communication

Education

Bachelor's degree in biomedical or related field

Job description

Abbott in Burlington, MA, is seeking a Regulatory Complaints Analyst within the Heart Failure Division to review customer complaints for regulatory reportability and compliance with GMPs and CFRs.

You will gather data from clinicians, field staff, and labs, draft MDRs and other regulatory reports, and communicate findings to relevant stakeholders. The role emphasizes timely, accurate documentation and cross-functional collaboration.