Adverse Events Specialist

Job Title: Adverse Events Specialist Job 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