Analyst I, Postmarket Surveillance

Abbott • Burlington, MA

1d • $50,700 - $101,300 • Onsite

About The Position

This position is based at Abbott’s Burlington, Massachusetts location in the Heart Failure Division. Abbott’s Heart Failure business develops solutions to diagnose, monitor, and manage heart failure. The Analyst I analyzes customer complaints to determine regulatory reportability, coordinates with internal, field, and end-use customers, and supports complaint handling in accordance with Good Manufacturing Practices, the Code of Federal Regulations, and other governmental regulations. The role communicates investigation results through regulatory reports and written communications as appropriate. The position includes 10% travel and is listed as a standard work shift.

Requirements

• Bachelor’s degree in biomedical science or a related field.
• 0–2 years of related work experience.

Responsibilities

• Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations.
• Participate in developing and modifying decision models in response to product and therapy advances to support consistent compliance with government regulations.
• Evaluate and investigate complaints by gathering data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Collect, compile, and document regulatory reportability decisions using event investigations and regulatory decision models.
• Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, and transmit them to appropriate regulatory authorities in a timely manner.
• Apply event codes to support product performance records.
• Review coding and investigations with engineering, laboratory, and other internal staff.
• Draft communications for physicians and other end-use customers describing clinical observations, investigations or product analysis, and corrective actions as applicable.
• Communicate determinations regarding eligibility for warranty credit or unreimbursed medical payments.
• Establish and cultivate a network of internal resources to facilitate completion of tasks.
• Complete daily work to the established schedule, receiving supervisor guidance on task prioritization; exercise authority within pre-established limits and approval.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage through the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level