MDR Compliance Specialist - Medical Devices
Medline
Location: Mundelein, Illinois, United StatesCompany: Medline IndustriesPosted: 2026-08-14Medline 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 submissions via eMDR, while coordinating with Quality, Regulatory Affairs, and R&D to gather needed information.The role requires a Bachelor’s degree with 1+ year of relevant experience and offers a path within a global#J-18808-Ljbffr
- ...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...Medical device
$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- ...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
- 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
- Overview Seeking contingent workers to support Medical Device Reporting (MDR) remediation activities, with a focus on retrospective complaint review... ...when remediation identifies reportable events. Support compliance with FDA Quality System Regulations, including complaint...Medical device
- 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...
- 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,...
- ...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
$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- ...verify completeness and reassess MDR reportability decisions.... ...reportable events. Support compliance with FDA Quality System Regulations... ...Strong ability to interpret medical narratives, product information... ...experience in a medical device or pharmaceutical environment...Medical device
$60k - $75k
...We are seeking passionate and driven Medical Device/Combination Product Engineers to join our medical device consulting team. This is an... ...applicable regulations, standards, and guidance documents to support compliance efforts Work closely with cross-functional teams,...Medical devicePermanent employmentFull timeTemporary workInternshipRemote 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
- ...Regulatory Affairs Specialist Responsible for filing necessary applications and handling all government interactions pertaining... ...approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience...Medical device
$30 - $50 per hour
...audits, documenting findings, and supporting compliance initiatives across domestic and... ...assist with supplier and vendor audits for medical device and pharmaceutical manufacturers. This individual... ...Audit CFR ISO CAPA MDR Medical Devices Reach Out to a...Medical deviceHourly payContract workTemporary workRemote work- ...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$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$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$60k - $120k
..., and training firm specializing in the medical device and combination products industry. We help... ...product development and ensure market compliance. We are seeking a dynamic and results... ...add value, including support for FDA and MDR compliance. Networking & Industry...Medical devicePermanent employmentFull timeTemporary workRemote workFlexible hours- ...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
- ...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
- ...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
$93.5k - $114.4k
...for customers worldwide. Description of Job: The Trade Compliance Specialist is responsible for supporting and maintaining the... ...quality healthcare coverage starting on day one, with options for medical (HSA/HRA), vision, and dental plans ~5% company contribution...Full timeWork at officeImmediate startWorldwideFlexible hours$79k - $119k
...affect patient safety. Prepare and submit Medical Device Reports (MDRs) to the FDA. Process MDRs... ...patient safety and risk data. Ensure compliance with applicable post-market regulations.... ...investigation. Maintain procedures for MDR/ Adverse Event Reporting for medical device...Medical deviceMinimum wageWork experience placementLocal areaWorldwide- ...45Remote50% RemoteRoles& Responsibilities:The Combination and Medical Device Products Consumable Device US team is expanding its support for... ...global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)Exceptional...Medical deviceWork at office
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