Job Description
Candidates should have hands‑on experience reviewing product complaints and determining MDR reportability in accordance with 21 CFR Part 803. Experience working in remediation or retrospective review projects is strongly preferred.
Responsibilities
- Review historical and current complaint files to confirm completeness and reassess MDR reportability decisions.
- Apply FDA MDR definitions and decision criteria to determine whether an MDR should have been filed.
- Identify missing or unclear information in complaint records and work with Quality, Regulatory, Operations, and other teams to obtain needed details.
- Prepare and submit MDRs through the FDA eMDR system when reportable events are identified.
- Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, while meeting tight remediation timelines.
This is a Contract position based out of Vernon Hills, IL.
Pay And Benefits
The pay range for this position is $28.00 - $35.00/hr.
Requirements
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)
This is a hybrid position in Vernon Hills,IL.
Application Deadline
This position is anticipated to close on May 20, 2026.
Diversity, Equity & Inclusion
At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Is Embedded Into Our Culture Through
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
About the company
Company website•Business Consulting and Services
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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research.
Actalent is an operating company of Allegis Group, the global leader in talent solutions.