Strategic Postmarket Surveillance Analyst II

Abbott; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Abbott is a global healthcare leader with a broad portfolio spanning diagnostics, medical devices, nutritionals and branded medicines. The Postmarket Surveillance Analyst will manage complaint handling, investigations, and regulatory reporting while collaborating with cross-functional teams to ensure patient safety and regulatory compliance.

The role involves reviewing complaint data, preparing technical evaluations, and maintaining documentation in accordance with FDA regulations and company

Qualifications

• Review complaint communications for regulatory compliance and patient safety impact.
• Independently perform investigations with customers or field staff.
• Prepare customer letters with investigation findings.
• Participate in cross-functional complaint review groups and archive records.
• Train new employees to the complaint handling process and support QA/Legal.

Responsibilities

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Communicates with field representatives and internal teams regarding information needed for product complaints, maintaining positive communications.
• Independently performs investigations with customers or field staff.
• Assess if a medical device report needs to be filed with global regulatory agencies and file within required timeframes.
• Prepare customer letters with investigation findings.
• Participate in cross-functional complaint review groups and archive records.
• Support the Quality Management Systems, EMS, and regulatory requirements.
• Train new employees and provide support to Legal regarding product complaints.

Skills

Regulatory compliance

Investigations

Cross-functional collaboration

Data entry

Medical devices knowledge

Job description

Abbott is a global healthcare leader with a broad portfolio spanning diagnostics, medical devices, nutritionals and branded medicines. The Postmarket Surveillance Analyst will manage complaint handling, investigations, and regulatory reporting while collaborating with cross-functional teams to ensure patient safety and regulatory compliance.

The role involves reviewing complaint data, preparing technical evaluations, and maintaining documentation in accordance with FDA regulations and company