Postmarket Surveillance Analyst I – Regulatory Reporting

Abbott; New Jersey; On-site; USD 51,000 - 101,000; Full time

Job summary

Abbott, a global healthcare leader, seeks a contributor for the Heart Failure division in Burlington, MA. this role analyzes customer complaints to determine regulatory reportability and coordinates with internal teams and customers, ensuring GMP adherence and proper handling of regulatory documents.

Responsibilities include drafting MDRs/MedWatch, applying codes to events, and communicating investigation findings to physicians and end users. 0-2 years of related experience preferred.

Qualifications

• Bachelor's degree in biomedical or related field is required.
• 0-2 years of related work experience required.
• Experience with GMPs and CFRs is preferred.

Responsibilities

• Review complaint communications for regulatory compliance and reportability.
• Investigate complaints using data from clinical staff, field reps, internal staff, and labs.
• Draft regulatory reports (MDRs, MedWatch, Vigilance) and ensure timely submissions.

Skills

GMP compliance

Regulatory reporting

Medical device regulations

Documentation and audits

Education

Bachelor's degree in biomedical or related field

Job description

Abbott, a global healthcare leader, seeks a contributor for the Heart Failure division in Burlington, MA. this role analyzes customer complaints to determine regulatory reportability and coordinates with internal teams and customers, ensuring GMP adherence and proper handling of regulatory documents.

Responsibilities include drafting MDRs/MedWatch, applying codes to events, and communicating investigation findings to physicians and end users. 0-2 years of related experience preferred.