This role is STARs-friendly: Skilled Through Alternative Routes.
34% STARs in role.
This role focuses on ensuring the quality, safety, and regulatory compliance of medical devices through robust complaint handling, MDR reportability assessments, post-market surveillance activities, CAPA support, and audit readiness. The specialist collaborates closely with cross-functional teams in Quality, Regulatory Affairs, Clinical, R&D, Operations, and other business stakeholders to maintain compliant processes, risk-based documentation, and audit-ready records aligned with FDA expectations and 21 CFR Part 803.
Responsibilities- Manage and process medical device complaints in accordance with complaint-handling requirements and internal quality system procedures.
- Perform MDR reportability assessments to determine whether events meet FDA medical device reporting criteria under 21 CFR Part 803.
- Support post-market surveillance activities by analyzing complaint data, identifying trends, and contributing to risk-based evaluations and reporting.
- Contribute to the development, implementation, and monitoring of Corrective and Preventive Actions (CAPA) to address product and process issues.
- Prepare, maintain, and organize quality system documentation to ensure it is accurate, complete, and audit-ready.
- Support audit readiness by maintaining thorough, well-documented records and providing evidence of compliance during internal and external audits.
- Document regulatory decision rationale clearly and consistently to support MDR submissions, complaint investigations, and quality records.
- Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders to ensure aligned and compliant processes.
- Use regulatory databases, tracking tools, complaint systems, and related platforms to track cases, actions, and outcomes.
- Participate in project coordination activities, managing multiple tasks and deadlines within a regulated environment.
- Interpret technical, scientific, complaint, and product information and translate it into clear regulatory decisions and documentation.
- Follow established workflows for eMDR/FDA reporting to ensure timely and accurate electronic submissions.
- Apply risk-based documentation practices to ensure appropriate levels of detail and justification in quality and regulatory records.
- Proven experience in medical device complaint handling and MDR reportability assessments.
- Practical exposure to FDA medical device reporting expectations and 21 CFR Part 803 requirements.
- Hands-on experience with quality system documentation and audit-ready recordkeeping in a regulated environment.
- Experience with eMDR/FDA reporting workflows and understanding of regulatory decision rationale.
- Strong technical writing skills with the ability to create clear, accurate, and compliant documentation.
- Strong analytical thinking and attention to detail in evaluating complaints, risks, and regulatory requirements.
- Demonstrated ability to prioritize, organize, and manage multiple deadlines in a fast-paced, regulated setting.
- Ability to interpret technical, scientific, complaint, and product information and translate it into regulatory decisions or documentation.
- Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
- Experience using regulatory databases, tracking tools, and complaint systems.
- Knowledge and use of SAP and TrackWise or similar quality and complaint management systems.
- Familiarity with FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related systems where applicable.
- Experience working within cross-functional teams including Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders.
- Background in medical device quality assurance, audit support, and regulatory compliance.
- Experience contributing to Corrective and Preventive Action (CAPA) programs.
- Exposure to risk-based documentation practices within a quality management system.
- Experience with RIMS or similar regulatory information management systems.
- Strong project coordination skills and comfort working under tight timelines.
- Excellent written and verbal communication skills suitable for a regulated environment.
This role is based within a large medical device organization and operates as part of a sizable, collaborative team. The environment is fast-paced, with tight deadlines and frequently changing day-to-day priorities. You will work extensively with digital tools and systems, including Microsoft Office, regulatory databases, tracking tools, complaint systems, SAP, TrackWise, RIMS, FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related platforms where applicable. The position requires comfort working in a structured, highly regulated setting with a strong focus on documentation accuracy, compliance, and continuous communication across multiple functions.
Job Type & LocationThis is a Contract position based out of Libertyville, IL.
Pay and BenefitsThe pay range for this position is $35.00 - $35.00/hr.
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)
Workplace TypeThis is a hybrid position in Libertyville,IL.
Application DeadlineThis position is anticipated to close on Aug 7, 2026.
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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006179499