Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the MDR Compliance Specialist - Medical Device Adverse Events in Mundelein, IL vacancy
  •  ...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

    Pentangle Tech Services | P5 Group

    Mundelein, IL
    1 day ago
  •  ...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 device
    Contract work

    MILLENNIUMSOFT

    Vernon Hills, IL
    5 days ago
  • $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 device
    Contract work
    Temporary work
    Work at office
    Monday to Friday

    Actalent

    Vernon Hills, IL
    4 days ago
  •  ...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 device
    Hourly pay

    eTeam

    Lake Forest, IL
    1 day ago
  •  ...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

    Katalyst CRO

    Mundelein, IL
    2 days ago
  •  ...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...  ...auditing Medical Device Reporting (MDR) documentation Knowledge... 
    Medical device
    Contract work
    Temporary work

    Accounting and Auditing Services

    Mundelein, IL
    1 day ago
  • $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 device
    Worldwide
    Shift work

    Abbott

    Buffalo Grove, IL
    2 days ago
  •  ...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

    Hire Talent

    Lake Forest, IL
    3 days ago
  •  ...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 device
    Contract work

    Unicon Pharma

    Lake Forest, IL
    1 day ago
  • $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 device
    Temporary work
    Remote work
    Monday to Friday

    Medical Devices and Supplies

    Mundelein, IL
    1 day ago
  • $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 device
    Work at office
    Worldwide
    Night shift

    Hollister

    Libertyville, IL
    5 days ago
  • $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 device
    Work at office
    Local area

    Tuta Healthcare Pty Ltd.

    Lake Forest, IL
    5 days ago
  • $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 device
    Work experience placement
    Worldwide

    Abbott

    Lake Forest, IL
    2 days ago
  •  ...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

    Unicon Pharma Inc

    Lake Forest, IL
    3 days ago
  • $140k - $191k

     ...single-use disposable medical products. This role drives...  ...use disposable medical devices.Provide leadership for...  ..., and design inputs in compliance with FDA 21 CFR 820.30...  ...Medical Device Regulation (MDR)ISO 13485IEC 62366 (...  ...sites, or industry events.Our Total Rewards package... 
    Medical device
    Work at office
    Worldwide

    Hollister

    Libertyville, IL
    1 day ago
  • $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 device
    Work at office
    Worldwide
    Visa sponsorship

    Hollister

    Libertyville, IL
    4 days ago
  •  ...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 Device
    Medical device
    Permanent employment

    Artech

    Vernon Hills, IL
    5 days ago
  •  ...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

    Katalyst Healthcares & Life Sciences

    Round Lake, IL
    2 days ago
  •  ...human factors, quality, clinical, medical safety, development, and...  ...combination product or medical device development; familiarity with...  ...ISO 14971, ISO 13485, and EU MDR preferred. Expertise in Systems...  ...various Design Control documents in compliance with applicable regulations.... 
    Medical device

    Spectraforce Technologies

    North Chicago, IL
    1 day ago
  • $60k - $120k

     ...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 device
    Full time
    Remote work
    Flexible hours

    Ventura Solutions LLC

    Barrington, IL
    2 days ago
  • 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 device
    Work at office

    Katalyst Healthcares & Life Sciences

    North Chicago, IL
    2 days ago
  •  ...oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements....  ...design transfer, and managing risk documentation across medical device product lines (Class I and Class II 510(k)). The engineer will... 
    Medical device

    Katalyst Healthcares and Life Sciences

    Mundelein, IL
    10 hours ago
  • $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 device
    Full time
    Work experience placement
    Visa sponsorship
    Flexible hours

    Flextronics

    Buffalo Grove, IL
    1 day ago
  •  ...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 device
    Contract work
    Shift work
    Day shift

    MILLENNIUMSOFT

    Vernon Hills, IL
    4 days ago
  •  ...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 device
    Contract work
    Local area
    Worldwide

    Katalyst Healthcares & Life Sciences

    North Chicago, IL
    5 days ago
  • $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 device
    Hourly pay
    Full time
    For contractors
    Immediate start
    Worldwide
    Flexible hours
    Shift work

    Sotera Health

    Gurnee, IL
    2 days ago
  • $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

    Connect Search

    Libertyville, IL
    4 days ago
  • $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 device
    Minimum wage
    Full time
    Local area
    Worldwide

    Medline

    Mundelein, IL
    2 days ago
  •  ...of 3 years of experience in packaging engineering within the medical device or drug development industries. Proven track record developing...  ...validation of content sterile packaging systems, ensuring compliance with regulatory standards. Experienced developing Packaging... 
    Medical device

    E-Solutions

    Vernon Hills, IL
    10 hours ago
  • $85k - $116.9k

     ...Typically requires a bachelor’s degree in engineering or equivalent experience and training.6+ years’ experience working within the Medical Device industry, with overall working experience of minimum 6 years in QualityAdvanced computer skills, including statistical analysis... 
    Medical device
    Full time
    Work experience placement
    Visa sponsorship
    Flexible hours

    Flextronics

    Libertyville, IL
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to MDR Compliance Specialist - Medical Device Adverse Events. Be the first to apply!