Remote Post-Market Medical Device Safety Specialist

Actalent; North Chicago (IL); Remote; USD 62,000 - 69,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k) Plan

Life Insurance

Short/Long Disability

PTO

Job summary

Actalent is seeking a dedicated Medical Device Safety Reviewer to collect, review, and process complaints and reports related to medical device adverse events in clinical studies, ensuring compliance with 21 CFR parts and FDA guidance.

The role focuses on post‑market safety, risk management, and supporting audits. It is remote with CST-aligned hours, contract from North Chicago, IL, and offers extensive benefits for a temporary role.

Qualifications

• RN with active license in good standing (any state)
• 4+ years of experience in post-market medical device safety/surveillance
• Proficiency in complaint handling and processing
• Experience with 21 CFR Part 803 and 806

Responsibilities

• Collect, review, assess, and process complaints and reports related to medical device adverse events and device deficiencies.
• Perform medical assessments for post-market device portfolio cases and elevate as needed.
• Maintain an understanding of medical device/combination product risk management regulations and applicable standards.
• Support and participate in audits and inspections as needed.
• Manage workload responsibilities related to safety management, including prioritizing workload, training, database reconciliation, and safety surveillance.
• Troubleshoot problems and elevate issues to the manager when necessary.
• Mentor and coach designated Medical Device Safety staff on assigned activities.

Skills

Medical Device Reporting

RN license

Post-market safety

Complaint handling

21 CFR Part 803/806

Education

BSN

Job description

Actalent is seeking a dedicated Medical Device Safety Reviewer to collect, review, and process complaints and reports related to medical device adverse events in clinical studies, ensuring compliance with 21 CFR parts and FDA guidance.

The role focuses on post‑market safety, risk management, and supporting audits. It is remote with CST-aligned hours, contract from North Chicago, IL, and offers extensive benefits for a temporary role.