Postmarket Surveillance Analyst I - Regulatory MDR Reports

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

Job summary

Abbott in Burlington, MA seeks an Analyst I in Postmarket Surveillance to review customer complaints, assess regulatory reportability, and coordinate with internal and external stakeholders. You will draft MDRs and regulatory communications, ensuring timely submission to authorities and adherence to CFR and GMP guidelines.

The role supports the Heart Failure division, with duties spanning data collection, investigation, and documentation for product performance and warranty considerations.

Qualifications

• Bachelor's degree in biomedical or related field required.

Responsibilities

• Review complaint communications for regulatory compliance and reportability.
• Draft Medical Device Reports (MDRs), MedWatch, and other regulatory reports.

Education

Bachelor's degree in biomedical or related field

Job description

Abbott in Burlington, MA seeks an Analyst I in Postmarket Surveillance to review customer complaints, assess regulatory reportability, and coordinate with internal and external stakeholders. You will draft MDRs and regulatory communications, ensuring timely submission to authorities and adherence to CFR and GMP guidelines.

The role supports the Heart Failure division, with duties spanning data collection, investigation, and documentation for product performance and warranty considerations.