MDR Compliance Specialist - Medical Device Adverse Events
Medline
Location: Mundelein, Illinois, United StatesCompany: MedlinePosted: 2026-07-27Medline in Mundelein, IL is seeking an Adverse Event Specialist to manage product complaint remediation and MDR reporting responsibilities. The role requires applying FDA 21 CFR 803 criteria and coordinating with cross-functional teams to ensure accurate reportability decisions.You will review historical and new complaints, determine regulatory obligations, and submit MDRs via the FDA eMDR portal while collaborating with international contacts as needed.#J-18808-Ljbffr
- Medline Industries, LP in Mundelein, IL is seeking an Adverse Event Specialist responsible for product complaint remediation and MDR reporting in compliance with FDA requirements. You will review and triage complaints, determine reportability under 21 CFR 803, and prepare...Medical device
- Medline Industries, LP in Mundelein, IL is seeking an Adverse Event Specialist to manage product complaint remediation and MDR reporting. You will review historical and new complaints to determine MDR reportability under FDA rules (21 CFR 803) and submit MDRs through the...Suggested
$67k - $101k
Job Summary The Adverse Event Specialist is responsible for both product complaint... ...complaints to determine MDR reportability in alignment... ...are completed in full compliance with FDA reporting requirements... ...understanding of FDA Medical Device Reporting (21 CFR 803) and...Medical deviceMinimum wageWork experience placementWork at officeLocal areaWorldwide- Medline Industries, LP is seeking an Adverse Event Specialist (Healthcare) to manage product complaints and MDR reporting. The role ensures FDA 21 CFR 803 compliance and leverages decision logic to determine reportability, coordinating with Quality, Regulatory Affairs,...Suggested
- ...Seeking contingent workers to support Medical Device Reporting (MDR) remediation activities, with a... ...remediation identifies reportable events. Support compliance with FDA Quality System... ...narratives, product information, and adverse event descriptions to assess severity...Medical device
- ...P5 Group is seeking contingent workers in Mundelein, IL to support Medical Device Reporting (MDR) remediation activities. The role involves reviewing historical complaint files for regulatory compliance, preparing MDR submissions, and ensuring adherence to FDA requirements...Medical device
$79k - $119k
...Product Surveillance Specialist (Security) Job Summary... ...incidents and submit adverse event reports. Provide... ...Prepare and submit Medical Device Reports (MDRs) to the... ...and risk data. Ensure compliance with applicable post-... ...Maintain procedures for MDR/ Adverse Event Reporting...Medical deviceMinimum wageWork experience placementLocal areaWorldwide$35 per hour
...Job Description Job Description Job Title: Medical Device Quality and Compliance Specialist Job Description As a Medical Device Quality and Compliance... ...will be responsible for handling complaints, conducting MDR reportability assessments, supporting post-market...Medical deviceContract workTemporary workWork at office- Katalyst CRO in Mundelein, Illinois, is seeking a candidate to support remediation activities under FDA requirements. This role involves reviewing historical complaint files, applying current FDA definitions, and preparing MDRs when necessary. The ideal candidate will have...
$35 per hour
...Job Description Job Description Job Title: Medical Device Quality and Compliance Specialist Hybrid role! Monday and Friday will work from home and Tuesday... ...in any of the following areas: complaint handling, MDR reportability assessments, post-market surveillance,...Medical deviceContract workTemporary workWork at officeMonday to Friday- ...product division. The role emphasizes identifying safety concerns, preparing Medical Device Reports to the FDA, coordinating international reporting, and conducting risk analyses to inform design changes and regulatory compliance. #J-18808-Ljbffr Medline Industries, Inc.Medical device
- ...completeness and reassess MDR reportability... ...identifies reportable events. Support compliance with FDA Quality System... ...ability to interpret medical narratives, product information, and adverse event descriptions to... ...experience in a medical device or pharmaceutical environment...Medical device
$68k - $136k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Buffalo... ...maintains the quality policy and ensures compliance to and is able to demonstrate...Medical deviceWorldwideShift work$30 - $33 per hour
...quality auditing experience within the medical device, pharmaceutical, or healthcare... ...regulated documentation (product complaints, adverse events, CAPAs, or similar)Exceptional attention... ...errors, inconsistencies, and compliance gapsStrong understanding of FDA Quality...Medical deviceTemporary work$96k - $140k
...and identify potential areas for improvements in the evolving Medical Device industry. You will build your professional experience by... ...including AOP and projections.Ensure understanding and adherence to compliance and accounting controls. Support ad-hoc reporting, including...Medical deviceWork at officeWorldwideNight shift- ICU Medical is seeking a Regulatory Affairs professional to support global and US registrations for medical devices. The role involves planning registration packages, liaising with agencies, and ensuring compliance across changes and submissions. Candidates should have...Medical device
- ICU Medical is seeking a Regulatory Affairs professional to support global and US registrations of medical device products. You will analyze regulatory requirements, create and maintain registration dossiers, and ensure compliance across submissions and change management...Medical device
- ...Grove, IL is seeking a Regulatory Affairs Specialist III to support day-to-day regulatory activities for new and existing medical devices. You will help develop global regulatory... ..., prepare US submissions, and ensure compliance with GMP and quality systems. You will collaborate...Medical device
- ...Recruiter - Unicon Pharma Inc Regulatory Affairs Specialist Provide regulatory support for U.S. and global medical device submissions, including FDA and EU requirements... ...of global regulatory strategies and ensure compliance for submissions and change management. Identify...Medical deviceContract work
$60k - $120k
...Medical Device Sales EngineerVentura Solutions is a leading consulting,... ...development and ensure market compliance.We are seeking a dynamic and... ...including support for FDA and MDR compliance.Networking & Industry... ...conferences, networking events, and webinars to promote our...Medical deviceRemote workFlexible hours- ...Senior Pharmaceutical Recruiter. The ideal candidate will provide regulatory support for both U.S. and global medical device submissions, focusing on compliance with FDA and EU requirements. Responsibilities include preparing registration packages, maintaining global...Medical device
$38 - $40 per hour
...40.00/hr Job Title: Quality Systems Specialist-Complaints Handling Location: Vernon... ...managing customer complaints, ensuring compliance with FDA and ISO regulations, and... ...requirements. Determine if complaints meet Medical Device Reporting (MDR) criteria and prepare Med Watch...Medical deviceRemote work$97.5k - $139.75k
...and expertise associated with global and US registration of medical device products, including in-depth analysis of the requirements and... ...maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management....Medical deviceWork at officeLocal area$60k - $75k
LHH Recruitment Solutions is working with a small and growing B2B business in the medical device industry who is looking to hire an Ecommerce Associate to oversee online sales operations, digital product listings, customer engagement, and marketing promotions. In this...Medical deviceLocal area$90k - $125k
...application of design controls in compliance with global regulatory requirements for medical devicesFacilitate project quality... ...with the EU MDD/MDR directives and regulations and ISO 13485 environment at a medical device manufacturerProject management training...Medical deviceWork at officeWorldwideVisa sponsorship$40 per hour
...advancing patient care through cutting-edge medical devices? In this role, you will play a key part... ...global submissions and ensuring compliance across international markets. You will... ...medical device regulations (specifically EU MDR/device regulations) Experience or...Medical deviceHourly payContract workTemporary workWork experience placementRemote work- ...new set of documentationUpload Bill of Material into MRP systemAdditional InformationAll your information will be kept confidential according to EEO guidelines.SummaryType: ContractFunction: Information TechnologyExperience level: Mid-Senior LevelIndustry: Medical DeviceMedical devicePermanent employment
- ...system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities... ...protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements...Medical device
- ...application of design controls in compliance with global regulatory requirements for medical devicesFacilitate project quality... .... Experience with the EU MDD/MDR directives and regulations and ISO 13485 environment at a medical device manufacturer. Project management...Medical deviceWork at officeVisa sponsorship
$100k - $130k
...Serving the automotive, aerospace, and medical device industries, they specialize in metal component... ...and execute strategies to address adverse quality trends and reduce the frequency... ...spending and maintaining budget compliance. Monitor Quality Engineering phone queue...Medical deviceLocal area
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