Regulatory Affairs Specialist II: MDR & Vigilance Expert
RXinsider LTD.
Abbott, a global healthcare leader, seeks a Regulatory Affairs Specialist II (Medical Events) in Lake Forest, IL on site. You will review and submit Medical Device Reports (MDRs) and vigilance reports, ensuring compliance with 21 CFR 803 and related regulations. You will work with Customer Service, Complaint Evaluations Group, and Complaint Investigations Group to determine MDR/reportability, file reports, and support quality system procedures within a dynamic global diagnostics environment. #J-18808-Ljbffr RXinsider LTD.
$61.3k - $122.7k
...and scientists. The Opportunity The Regulatory Affairs Specialist II (Medical Events) position supports the... ...(MDRs), including international vigilance reports for the division’s products.... ...additional information needed to determine MDR and/or Vigilance reportability....SuggestedWorldwide$68k - $136k
...United States > Lake Forest : CP01Job Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 2026-08-17Abbott is... ...lab results for millions of people. The Regulatory Affairs Specialist II is responsible for implementing and maintaining the effectiveness...SuggestedWork experience placementWorldwide- A leading biopharmaceutical company is seeking a Scientist II in Genomic Technologies. The successful candidate will conduct genomic profiling, collaborate on experiments, and maintain genomic platforms. A required qualification is an MS in molecular biology or related...Suggested
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- ...functional teams to meet study objectives. The role requires advanced EDC experience (Medidata RAVE), knowledge of CDASH/SDTM, and strong regulatory compliance awareness. A Master’s degree is preferred and mentorship of colleagues is expected. #J-18808-Ljbffr AllerganSuggested
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- ...Medline in Mundelein, IL is seeking an Adverse Event Specialist to manage product complaint remediation and MDR reporting responsibilities. The role requires... ...will review historical and new complaints, determine regulatory obligations, and submit MDRs via the FDA eMDR...
- Position Title: QA Compliance Specialist II Work Location: 60064, North Chicago, IL Assignment Duration: 06 Months (Possible extension) Work Arrangement: Onsite (warehouse floor support required) Position Summary: Assure compliance with FDA current Good manufacturing Practices...
- HD Supply Canada, Inc is seeking a Customer Care Associate II in Waukegan, IL. This role involves providing exceptional customer service by responding to inquiries about product selection and resolving issues effectively. Associates are expected to have knowledge of 20...
- Cox in Wheeling, IL is looking for a Mobile Diesel Technician Level II to perform DOT inspections and maintenance on heavy-duty vehicles in a mobile environment. The ideal candidate will have at least 3 years of experience, a high school diploma, and the ability to manage...Hourly pay
- ...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... ...FDA eMDR portal, collaborating with Quality, Regulatory Affairs, R&D, and Operations to gather required...
- Medline Industries, LP is seeking an Adverse Event Specialist (Healthcare) to manage product complaints and MDR reporting. The role ensures FDA 21 CFR 803... ...determine reportability, coordinating with Quality, Regulatory Affairs, and R&D. The position requires a bachelor's...
- ...in Mundelein, IL is seeking an Adverse Event Specialist responsible for product complaint remediation and MDR reporting in compliance with FDA requirements.... ...submissions via eMDR, while coordinating with Quality, Regulatory Affairs, and R&D to gather needed information. The...
- Medline Industries, LP is seeking an Adverse Event Specialist to review complaints and determine MDR reportability, ensuring compliance with FDA... ...historical complaints, and collaboration with Quality, Regulatory Affairs, R&D and Operations. A Bachelor's degree and 1+ year...
- SGS is seeking a qualified lab equipment specialist to maintain instrument readiness and ensure regulatory compliance during testing activities. You will interpret calibration records, lead Out-of-Tolerance resolutions, and support improvement projects across the department...
- ...controls, supplier management, deviations, documentation, CAPA, audits, experience with supplier change notifications, searching vendors in SAP, Soltraqs/Trackwise experience. Experience in a Regulatory Pharmaceutical Industry. #LI-KH1 #J-18808-Ljbffr The Fountain Group
- ...pharmaceutical company in North Chicago is seeking a Quality Assurance Specialist to monitor Supplier Change Notifications and ensure compliance... ...in a Science or Engineering field. Familiarity with SAP and Regulatory Pharma is essential. This role provides an opportunity to work...
$100 per hour
...leading LLM companies. Offer Details Pay rate: $100+/hour (depends on role and candidate expertise) Assessment: Shortlisted experts complete an evaluation before selection. Assignments: Contract roles with defined start/end dates; up to 40 hrs/week. About...Hourly payContract workRemote workFlexible hours- ...Role Overview Turing invites Legal Experts to join projects that fine-tune AI models like ChatGPT. If you enjoy applying legal reasoning, analyzing complex cases, and providing clear, structured feedback, this is your chance to put your expertise to work in a new way....FreelanceRemote workFlexible hours
$54k - $66k
...sleep well so they live well is at the core of what we do. The right mattress matters, and so does the right career. Our Sleep Experts® are at the heart of what we do: helping customers find their dream mattress and get better sleep. By joining our team, you'll get...- ...Job Title: Regulatory Affairs Associate. Location: Lake Forest, IL Duration: 12 Months Pay Rate: $33-$35 on W2 per hour. Position... ...with 510(k) eSubmitter electronic submission template, MDR and regional regulatory submissions, seeking guidance when necessary...Hourly pay
- HD Supply in Illinois is seeking a customer service associate to respond to inquiries about product selection, services and issues. You will maintain knowledge on 20,000 products and 3 catalogs to assist customers effectively. You will handle orders and quotations by phone...
$120k - $160k
...About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences... ...to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals...Full time$117.3k - $195.5k
...levels, including MCCDH Planning and Impact team and Medical Affairs executive-level stakeholders Allow visualization of metrics and... ...including scientific/technical, promotional, patient/consumer, regulatory, and media. In depth understanding of the business of...Remote workRelocation packageFlexible hours$30 - $35 per hour
...Description Quality Assurance Compliance Specialist Contract: North chicago, Illinois,... ...Quality Assurance Compliance Specialist II Location: North Chicago, IL 60064... ...for ensuring compliance with regulatory requirements, quality standards, and internal...Hourly payContract workTemporary work- 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...
- 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...
- 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...
- ...seeking a detail-oriented, experienced Regulatory Affairs Consultant to join our team on a contract... ...global market access (FDA, Health Canada, EU MDR, and other international markets)... ...experience with both Class I and Class II medical devices Strong working knowledge...Contract workRemote work
- ...You will perform mass spectrometry, chromatography, amino acid analysis, and higher-order structure work to support process and regulatory goals. The role emphasizes independent experimental design, collaboration with cross-functional teams, and adherence to GxP standards...
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