MDR Compliance Specialist - Medical Device Adverse Events
Medline
Location: Mundelein, Illinois, United StatesCompany: MedlinePosted: 2026-08-19Medline 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 1 day ago
Similar jobs that could be interesting for youBased on the MDR Compliance Specialist - Medical Device Adverse Events in Mundelein, IL vacancy
- 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
- Medline Industries, LP is seeking an Adverse Event Specialist to review complaints and determine MDR reportability, ensuring compliance with FDA reporting requirements (21 CFR 803) and Quality System regulations. The role involves remediation and processing of new and...Suggested
- 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
$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- ...seeks a Regulatory Affairs Specialist II (Medical Events) in Lake Forest, IL on site.... ...will review and submit Medical Device Reports (MDRs) and vigilance reports, ensuring compliance with 21 CFR 803 and related... ...Group to determine MDR/reportability, file reports,...Medical device
- ...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
- 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...
$104k - $143k
...role at BaxterAs a Principal Specialist, Global Regulatory Affairs,... ...for an assigned portfolio of medical device products across the U.S., EU... ...maintain market access and compliance throughout the product lifecycle... ...to FDA requests.Maintain EU MDR regulatory documentation and...Medical deviceFull timeTemporary workWork visaFlexible hours- ...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, IL16 hours ago - ...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
- ...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
eTeam
Lake Forest, IL4 days ago $26 - $42 per hour
...the next step in your manufacturing or engineering career? Join us at our upcoming hiring event to interview for multiple Technician opportunities with a leading medical device manufacturer specializing in precision injection molding and highly automated manufacturing...Medical deviceHourly payFull timeTemporary workWork experience placementImmediate startRotating shiftVolt
Libertyville, IL2 days ago$61.3k - $122.7k
...products in diagnostics, medical devices, nutritionals and branded... ...Opportunity The Regulatory Affairs Specialist II (Medical Events) position supports the... ...accountable for ensuring compliance with Medical Device... ...information needed to determine MDR and/or Vigilance...Medical deviceWorldwide$104k - $143k
...role at Baxter As aPrincipal Specialist, Global Regulatory Affairs,... ...for an assigned portfolio of medical device products across the U.S., EU... ...maintain market access and compliance throughout the product lifecycle... ...FDA requests. Maintain EU MDR regulatory documentation and...Medical deviceTemporary workWork visaFlexible hours$68k - $136k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...millions of people. The Regulatory Affairs Specialist II is responsible for implementing and... ...maintains the quality policy. Ensures compliance and is able to demonstrate knowledge...Medical deviceWork experience placementWorldwide- ...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, IL1 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 deviceWorldwideShift 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
- Baxter Healthcare is seeking a Principal Specialist, Global Regulatory Affairs to lead regulatory activities for a portfolio of medical device products in the U.S., EU, and globally.... ...that maintain market access and compliance throughout the product lifecycle. You will...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 - $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 workVentura Solutions LLC
Vernon Hills, ILmore than 2 months ago$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 workCollabera Technologies
Mundelein, IL2 days ago$26 - $42 per hour
...the next step in your manufacturing or engineering career? Join us at our upcoming hiring event to interview for multiple Technician opportunities with a leading medical device manufacturer specializing in precision injection molding and highly automated manufacturing...Medical deviceHourly payFull timeTemporary workWork experience placementImmediate startRotating shiftVolt
Wheeling, IL2 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
$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
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!
Related searches
- medical device Mundelein, IL
- compliance lead Mundelein, IL
- compliance team leader Mundelein, IL
- compliance Mundelein, IL
- regulatory affairs assistant Mundelein, IL
- customs compliance Mundelein, IL
- regulatory affairs Mundelein, IL
- compliance technician Mundelein, IL
- regulatory compliance Mundelein, IL
- manager special events Mundelein, IL