Postmarket Surveillance Analyst I: Regulatory & MDRs

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

Job summary

Abbott, headquartered in the Burlington, MA area, is seeking a candidate for the Heart Failure division to analyze customer complaints for regulatory reportability and ensure GMP adherence. The role involves coordinating with internal teams and customers, drafting regulatory documents, and maintaining compliance with CFR requirements.

The successful candidate will work under supervision with increasing responsibility, perform data collection and investigation to support MDRs and related reports,

Qualifications

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

Responsibilities

• Review complaint communications for regulatory compliance and reportability, assessing impact to patient safety and operations.
• Participate in development and modification of decision models to maintain compliance with government regulations.
• Investigate complaints by gathering data from clinical staff, field reps, internal staff and labs.
• Document regulatory reportability decisions using event investigation models.
• Draft MDRs, MedWatch, Vigilance and other regulatory reports for timely submission to authorities.
• Apply codes to events to facilitate product performance records.
• Review coding and investigations with engineering and lab staff.
• Draft written communications detailing observations, investigations, and actions to physicians and customers.

Education

Bachelor's degree in biomedical or related field

Job description

Abbott, headquartered in the Burlington, MA area, is seeking a candidate for the Heart Failure division to analyze customer complaints for regulatory reportability and ensure GMP adherence. The role involves coordinating with internal teams and customers, drafting regulatory documents, and maintaining compliance with CFR requirements.

The successful candidate will work under supervision with increasing responsibility, perform data collection and investigation to support MDRs and related reports,