MDR Compliance Specialist - Medical Devices
Medline
Location: Mundelein, Illinois, United StatesCompany: Medline Industries, LPPosted: 2026-08-08Medline 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
- ...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
- ...MillenniumSoft Inc is seeking a Quality Analyst for a 10+ months contract in Vernon Hills, IL. The role involves ensuring compliance with quality system standards and managing customer complaints, including investigation and development of corrective actions. Candidates...Medical deviceContract work
$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- ...electronic publishing and submission of medical devices, including understanding the structure... ...registration dossiers. Assures full regulatory compliance of all documentation for submissions... ...electronic submission template, MDR and regional regulatory submissions, seeking...Medical deviceHourly pay
$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- ...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
- ...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
- ...verify completeness and reassess MDR reportability decisions. Apply... ...reportable events. Support compliance with FDA Quality System Regulations... .... Strong ability to interpret medical narratives, product... ...remediation experience in a medical device or pharmaceutical environment...Medical device
$17.5 - $20.5 per hour
...Adecco is seeking dedicated Molding Operators to join our team for a leading medical device manufacturer in Wheeling, IL. This is an excellent opportunity to join a reputable company that prioritizes quality and precision in the medical industry. At Adecco, we are committed...Medical deviceHourly payWeekly payTemporary workLocal areaImmediate startShift workNight shiftRotating shiftDay shiftAfternoon shift$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$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
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...than 160 countries. Regulatory Affairs Specialist II Working at Abbott At Abbott, you can... ...maintains the quality policy. Ensures compliance and is able to demonstrate knowledge of...Medical deviceWork experience placementWorldwide- ...Ensure the accuracy, completeness, and compliance of product complaint documentation by conducting... ...Quality Auditing experience within the medical device, pharmaceutical, or healthcare industry... ...auditing Medical Device Reporting (MDR) documentation Knowledge of complaint...Medical deviceContract workTemporary 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
$140k - $191k
...management of single-use disposable medical products. This role drives... ...use disposable medical devices.Provide leadership for product... ...needs, and design inputs in compliance with FDA 21 CFR 820.30 Design... ...requirementsEU Medical Device Regulation (MDR)ISO 13485IEC 62366 (Usability...Medical deviceWork at officeWorldwide$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- ...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
$60k - $120k
...Medical Device Sales Engineer Ventura Solutions is a leading consulting, staffing, and training... ...product development and ensure market compliance. We are seeking a dynamic and results... ...value, including support for FDA and MDR compliance. Networking & Industry Presence...Medical deviceFull timeRemote workFlexible hours- Roles& Responsibilities:The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices... ...global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)Exceptional...Medical deviceWork at office
- ...and maintained on market while assuring compliance to local, divisional, and corporate... ...regulations worldwide. Products include medical devices and combination products, such as infusion... ...Regulation 93/42/EEC (MDD) & 2017/745 (MDR). Working knowledge of international...Medical deviceContract workLocal areaWorldwide
$120k - $125k
...I'm partnering with a global medical device manufacturer headquartered in Lake County on a newly created Lead Financial Analyst seat supporting their Canadian business unit. This is not a reporting role. The hiring manager was direct about what he's looking for: someone...Medical device- ...years of experience in pharmaceutical, medical device, combination product, or other regulated... ...creating various Design Control documents in compliance with applicable regulations ~ Strong... ...Part 4, ISO 14971, ISO 13485, and EU MDR preferred. Expertise in Systems Engineering...Medical device
$101k - $152k
...of the quality control group to ensure quality and regulatory compliance for assigned division.Job DescriptionResponsibilitiesAssist... ...Work ExperienceAt least 3 years experience in pharmaceutical or medical device good manufacturing practices.Additional SkillsIntermediate...Medical deviceMinimum wageFull timeLocal areaWorldwide$20 per hour
...is an excellent opportunity to enhance your career within the medical device industry. Adecco is actively hiring dedicated professionals... ...orders to accurately assemble catheter components. Maintain compliance with all quality standards, GMP, and regulatory requirements....Medical deviceHourly payTemporary workLocal areaMonday to FridayShift workAfternoon shift$112k - $154k
...in Mechanical, Electrical, Computer Science, Biomedical Engineering or related field.5+ years of relevant industry experience.Medical device industry experience is preferred.Requires strong organization and communication skills, with the ability to interface with both...Medical deviceFull timeTemporary workWork visaFlexible hours$32 - $35 per hour
...to applicable eligibility requirements: medical insurance, dental insurance, vision insurance... ..., and quality records to ensure compliance with FDA regulations, internal procedures... ...Auditing experience within the medical device, pharmaceutical, or healthcare industry...Medical deviceTemporary workRemote workMonday to Friday$17 - $18 per hour
...including electric vehicles, aerospace, factory automation, medical devices, and telecommunications. With a strong focus on safety, teamwork... ...and packaging materials to ensure quality, accuracy, and compliance with specifications. Monitor packaging processes and...Medical deviceFull timeTemporary workWork experience placementLocal areaWorldwideMonday to Friday$110k - $120k
...yr Lead Technical Recruiter/Sales Executive Manufacturing | Medical Devices We are seeking an experienced Environmental, Health & Safety... ...leader, with a strong focus on plant‑floor safety, regulatory compliance, and safety culture. This position is ideal for an EHS...Medical deviceFull timeContract workLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to MDR Compliance Specialist - Medical Devices. Be the first to apply!
- medical device Mundelein, IL
- compliance Mundelein, IL
- regulatory affairs Mundelein, IL
- regulatory affairs assistant Mundelein, IL
- compliance team leader Mundelein, IL
- regulatory compliance Mundelein, IL
- compliance lead Mundelein, IL
- compliance technician Mundelein, IL
- compliance officer part time
- quality assurance compliance specialist

