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
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$35 per hour
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...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- ...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
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$28 - $30 per hour
...accuracy, completeness, and compliance of product complaint documentation... ...of product complaint files, adverse event documentation, and quality... ...experience within the medical device, pharmaceutical, or healthcare... ...Medical Device Reporting (MDR) documentation Knowledge...Medical deviceHourly payContract workTemporary work$68k - $136k
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$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$32 - $35 per hour
...applicable eligibility requirements: medical insurance, dental insurance,... ...of product complaint files, adverse event documentation, and quality records to ensure compliance with FDA regulations, internal... ...experience within the medical device, pharmaceutical, or healthcare...Medical deviceTemporary workRemote workMonday to Friday$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$68k - $136k
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...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- ...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
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$25 - $30 per hour
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...Medical Device Sales Engineer Ventura Solutions is a leading consulting... ...and ensure market compliance. We are seeking a dynamic... ...including support for FDA and MDR compliance. Networking & Industry... ...industry conferences, networking events, and webinars to promote our...Medical deviceFull timeRemote workFlexible hours- ...Project Manager to lead New Product Introduction projects in a medical device manufacturing environment. The role focuses on driving cross‑... ...Chain, and Regulatory teams, manage timelines and budgets, and ensure FDA/GMP compliance throughout the product #J-18808-Ljbffr...Medical device
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$86.3k - $118.7k
...Office, e.g. Excel, etc.Above work experience from the following types of companies required: mold design / mold making and/or medical device manufacturing (or similar).Ideal/highly desirable work experience: Expert knowledge in injection plastic molding and tooling experienceSolidWorks...Medical deviceFull timeWork experience placementVisa sponsorshipFlexible hours- ...12 months Total Hours/week: 40.00 Shift: 1st Shift Client: Medical Devices Company Job Category: Engineering/Technical Senior level: Entry... ...practice (GDP), good laboratory practice (GLP) and supports compliance with GLP. Supports efforts to create tools for process...Medical deviceContract workShift workDay shift
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$46k - $72k
...customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.... ...that product is processed, and employee practices are in compliance with industry GMPs, OSHA and all applicable standards. Assists...Medical deviceHourly payFull timeFor contractorsImmediate startWorldwideFlexible hoursShift work
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