Postmarket Surveillance Analyst I

RXinsider LTD.; Plano, Northern (TX, KY); Hybrid; USD 51,000 - 101,000; Full time

Benefits offered by this job

Career development

Free medical coverage (HIP PPO)

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Recognition

Job summary

Abbott is seeking an Analyst I Postmarket Surveillance in Plano, TX to manage complaint investigations and regulatory reporting for medical devices. You will enter data, coordinate testing, and prepare reports while collaborating with cross-functional teams.

This role requires a healthcare or science background, strong communication, and the ability to handle multiple investigations in a fast-paced environment. Equal opportunity employer; base pay disclosed in policy.

Qualifications

• Experience with medical device complaint handling and regulatory reporting is preferred.
• Strong written and oral communication skills are required.
• Ability to work independently and manage multiple investigations simultaneously.
• Knowledge of FDA and global medical device reporting requirements is a plus.
• Multitasks, prioritizes, and meets deadlines with strong organizational skills.

Responsibilities

• Investigate complaints and determine whether a medical device report is needed, and file as required.
• Maintain accurate entry of complaints in the database and coordinate cross-functional reviews.
• Prepare technical reports of findings and customer letters based on investigations.
• Coordinate product testing/analysis with other departments and external consultants.
• Support regulatory inspections and audits and assist in data trending for the department.
• Maintain lab equipment and coordinate product testing.

Skills

Complaint handling

Regulatory knowledge

Data entry

Investigations

Multitasking

Education

Bachelor's degree in healthcare or science

2-year degree with relevant experience

Job description

Abbott is seeking an Analyst I Postmarket Surveillance in Plano, TX to manage complaint investigations and regulatory reporting for medical devices. You will enter data, coordinate testing, and prepare reports while collaborating with cross-functional teams.

This role requires a healthcare or science background, strong communication, and the ability to handle multiple investigations in a fast-paced environment. Equal opportunity employer; base pay disclosed in policy.