Postmarket Surveillance Analyst - Quality & Compliance

RXinsider LTD.; Burlington (MA); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Career development

Free medical coverage (HIP PPO)

Retirement savings plan

Tuition reimbursement

FreeU education benefit

Diversity recognition

Job summary

Abbott is seeking a Postmarket Surveillance Analyst to manage complaint handling and product evaluations for a global healthcare portfolio. You will investigate reports, determine regulatory reporting needs, and coordinate with Regulatory, QA, and Legal teams to ensure timely MDR submissions where applicable.

The role emphasizes independent work, cross-functional collaboration, and adherence to FDA regulations.

Qualifications

• Knowledge of global medical device reporting regulations and terminology.
• Experience supporting complaint handling investigations or medical device reporting.
• Strong written and oral communication skills.
• Ability to work both independently and in cross-functional teams.

Responsibilities

• Review complaints for regulatory compliance and reportability, maintain complaint databases.
• Independently conduct investigations with customers or field staff and determine regulatory reporting needs.
• Prepare technical evaluation reports and coordinate testing with internal/external teams.
• Train new staff on complaint handling processes and support QA/Legal as needed.

Skills

Regulatory knowledge

Communication skills

Independent work

Problem solving

Time management

Team collaboration

Multitasking

Travel readiness

Education

Associate’s degree or equivalent

Bachelor’s degree or equivalent

Tools

Computer proficiency

Job description

Abbott is seeking a Postmarket Surveillance Analyst to manage complaint handling and product evaluations for a global healthcare portfolio. You will investigate reports, determine regulatory reporting needs, and coordinate with Regulatory, QA, and Legal teams to ensure timely MDR submissions where applicable.

The role emphasizes independent work, cross-functional collaboration, and adherence to FDA regulations.