Medical Device Safety Reviewer

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

Job Description

Job Title: Medical Device Safety Reviewer

Job Description

We are seeking a dedicated Medical Device Safety Reviewer to collect, review, assess, and process complaints and reports related to medical device adverse events and device deficiencies in clinical studies. This role requires compliance with global regulations, including seriousness assessment, labeling, causality, and follow-up data received. The reviewer will perform medical assessments for post-market device portfolio cases and elevate as needed to the MDS physician. The ideal candidate will maintain an understanding of medical device/combination product risk management regulations and applicable standards and guidance documents. The position supports and participates in audits and inspections as needed.

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 primarily related to medical device safety management, including prioritizing workload, training, database reconciliation, and safety surveillance.
• Troubleshoot problems and elevate issues to the manager as necessary.
• Mentor and coach designated Medical Device Safety staff on assigned activities.

Essential Skills

• Expertise in Medical Device Reporting.
• Registered Nurse with active RN 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 21 CFR Part 806.

Additional Skills & Qualifications

• Bachelor of Science in Nursing (BSN).
• Experience with combination product quality assurance (QA).
• Familiarity with quality management systems (QMS) and FDA regulations.

Work Environment

This position offers a 100% remote work environment with expected working hours aligned to Central Standard Time (CST).

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits

The pay range for this position is $45.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Application Deadline

This position is anticipated to close on Oct 16, 2026.

Workplace Type

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.