Job Title: Adverse Events SpecialistJob Description
The Adverse Events Specialist is responsible for product complaint remediation and for processing new complaints to determine regulatory reportability. This role reviews both historical and newly received complaints to assess Medical Device Reporting (MDR) requirements in accordance with current procedures, 21 CFR 803, FDA regulations, and internal quality system standards. The specialist ensures that all MDR submissions are accurate, complete, and fully compliant with applicable regulatory and quality requirements, supporting post-market surveillance and patient safety.
Responsibilities
Review new and historical product complaints to verify data completeness and accuracy.
Evaluate complaint files to determine MDR reportability under 21 CFR 803, using current criteria, definitions, decision trees, and decision logic.
Ensure that reportability decisions align with current regulatory standards, internal procedures, and quality system regulations.
Perform product complaint remediation by reassessing historical complaints for MDR reportability and updating records as needed.
Prepare and submit MDRs through the FDA's electronic submission portal (eMDR) for newly identified reportable events.
Work cross-functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to obtain missing complaint or product information needed for accurate reportability assessments.
Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations related to adverse events and product complaints.
Support post-market surveillance activities by identifying trends and ensuring appropriate documentation of adverse events and product complaints.
Apply GxP and GCP principles in all complaint handling, documentation, and reporting activities to maintain a high standard of regulatory compliance.
Maintain clear, organized, and audit-ready records for all complaint evaluations and MDR submissions.
Essential Skills
Bachelor's degree in a relevant field.
At least 1 year of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or other relevant experience within a regulated environment or healthcare setting.
A minimum of 2 years of hands-on experience with medical device reporting under 21 CFR 803.
Strong knowledge of FDA Medical Device Reporting (MDR) requirements and 21 CFR 803.
Experience in adverse event evaluation and case processing in a regulated @context.
Familiarity with pharmacovigilance, drug safety, or surveillance activities.
Working knowledge of regulatory affairs practices within the pharmaceutical or medical device industry.
Understanding of GxP and GCP principles and their application to complaint handling and reporting.
Ability to interpret and apply regulatory criteria, definitions, and decision logic to determine reportability.
Strong attention to detail and accuracy in documentation and data review.
Ability to collaborate effectively with cross-functional teams, including Quality, Regulatory Affairs, R&D, and Operations.
Additional Skills & Qualifications
Experience preparing and submitting MDRs via the FDA's electronic submission portal (eMDR).
Background in pharmaceutical, medical device, or healthcare environments supporting regulatory compliance and safety reporting.
Experience working with international regulatory contacts or supporting global reporting obligations.
Strong written and verbal communication skills for clear documentation and cross-functional collaboration.
Ability to manage multiple complaint cases and reporting deadlines in a structured and organized manner.
Work Environment
This position operates in a hybrid work environment, with on-site work required three days per week (Tuesday, Wednesday, and Thursday) in Mundelein, IL, and remote work on the remaining days as permitted. The role involves close collaboration with Quality, Regulatory Affairs, R&D, Operations, and other internal teams, as well as interaction with regulatory contacts. The work is primarily office-based, focused on detailed review of complaint files, electronic documentation, and use of regulatory systems such as the FDA's eMDR portal. The organization provides a professional setting within a large provider of medical-surgical products and supply chain solutions, supporting all points of care and emphasizing regulatory compliance, patient safety, and high-quality standards.
Job Type & Location
This is a Contract to Hire position based out of Mundelein, IL.
Pay and Benefits
The pay range for this position is $35.00 - $40.00/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 Type
This is a hybrid position in Mundelein,IL.
Application Deadline
This position is anticipated to close on May 13, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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.
