Regulatory MDR & Adverse Event Specialist
Medline
Medline Industries, LP is seeking an Adverse Event Specialist to manage product complaint remediation and determine MDR reportability under FDA rules. You will review historical and new complaints to ensure accurate reporting and full compliance with 21 CFR 803 and Quality System requirements. The role requires a bachelor's degree and 1+ year in a regulated environment, with cross‑functional collaboration across Quality, Regulatory Affairs, R&D, and Operations. #J-18808-Ljbffr 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... ...FDA eMDR portal, collaborating with Quality, Regulatory Affairs, R&D, and Operations to gather required...Regulatory
$67k - $101k
Job Summary The Adverse Event Specialist is responsible for both product complaint remediation and processing new... ...and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR...RegulatoryMinimum wageWork experience placementWork at officeLocal areaWorldwide- ...support Medical Device Reporting (MDR) remediation activities, with... ...cross‑functionally (Quality, Regulatory, Operations, etc.) to obtain... ...remediation identifies reportable events. Support compliance with FDA... ..., product information, and adverse event descriptions to assess severity...Regulatory
- 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... ...reportability, coordinating with Quality, Regulatory Affairs, and R&D. The position requires a bachelor...Regulatory
- ...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. Candidates...Regulatory
- ...Industries, LP in Mundelein, IL is seeking an Adverse Event Specialist responsible for product complaint remediation and MDR reporting in compliance with FDA requirements... ...via eMDR, while coordinating with Quality, Regulatory Affairs, and R&D to gather needed information...Regulatory
- Fresenius Kabi USA, LLC seeks an experienced drug safety lead to manage adverse drug event processing and FDA reporting. You will collaborate with Global Vigilance and Quality to maintain regulatory compliance and provide expert medical review. The role requires 8+...Regulatory
- ...-04553 Responsibilities: Accurate and timely registration of adverse event and product quality report from initial receipt to data entry... ...Medical terminology knowledge preferred. Prior experience in a regulatory/medical setting preferred. Candidates must posses 3 to 5...RegulatoryWork experience placement
- Sysmex Corporation in Lincolnshire, IL, seeks a Laboratory Specialist II to support in‑house studies on Sysmex instruments and similar instruments within the Regulatory and Clinical Affairs (RACA) Laboratory. The role includes maintenance and QC of lab equipment and collaboration...RegulatoryWork at office
- Sysmex America, Inc. in Illinois is seeking a Laboratory Specialist II to support in-house studies on Sysmex instruments and similar products in the Regulatory and Clinical Affairs Laboratory. The role also covers maintenance and QC of laboratory equipment. You will perform...Regulatory
- ...Description The Controls Specialist supports the execution, monitoring, and continuous improvement of the firm’s internal control reporting... ...testing, and ensuring accurate, timely reporting aligned with regulatory requirements, client expectations, and internal policies....RegulatoryWork at officeRemote work
- 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... ...Group, and Complaint Investigations Group to determine MDR/reportability, file reports, and support quality system...Regulatory
- ...Job title: Project Specialist Location: Mettawa, IL 60045 Duration: 12 months (possible Extension) Hybrid on-site 3 days/week. Company... ...approval process (Kantata, Workfront) Understand the Medical/Legal/Regulatory (Veeva) review process and prepare all assets and...Regulatory3 days per week
$34.32 - $53.94 per hour
...currently have a great opportunity available for a Laboratory Specialist II. The Laboratory Specialist II in this role will support in‑... ...Sysmex instruments and similar instruments and products in the Regulatory and Clinical Affairs (RACA) Laboratory. In addition, the...RegulatoryHourly payTemporary workWork at officeWorldwideShift work$85k - $95k
Job Title: Sr. Specialist, Payroll Reports To: Director, Total Rewards Position Location: Vernon Hills, IL (Hybrid) FLSA Status (Exempt... ...activities, including W-2 / T-4 forms, payroll tax reconciliations, regulatory reporting, etc. Serve as subject matter expert for payroll...RegulatoryLocal areaRelocation package$64.7k - $80.9k
Job Description Develop and administer facility Environmental, Health, and Safety (EHS) programs in accordance with regulatory requirements and corporate policies, standards, procedures, and objectives. Foster facility awareness, involvement, and accountability of EHS...RegulatoryFull timeTemporary workFor contractorsFlexible hours- ...Reference26-01373Job Summary: We are seeking a Change Control Specialist to support change management and documentation activities within... ...and instrument qualification activities. Collaborate with QA, Regulatory, Supply Chain, Analytical, and other cross-functional teams....RegulatoryWork at officeLocal areaRelocation
- ...primarily in Lake County, IL. The role supports global initiatives, trains frontline staff, and ensures compliance with policy and regulatory requirements. You will work with Security, HR, Talent Acquisition, and contractors, calibrating access levels, auditing...RegulatoryFor contractors
- ...Staffing and Services Firm, has an opening for a Compensation Specialist at a global leader in retail pharmacy for a 6-month contract.The... ...recruitment (as it relates to policy), personnel policies and regulatory compliance.Advise managers and employees on state and federal...RegulatoryContract work
- ...with enterprise security standards, including CIS Benchmarks for Azure, Microsoft Cloud Security Benchmark (MCSB), and internal control frameworks.• Maintain pipeline audit trails and artefact provenance in alignment with SOC 2, ISO 2700 1, and regulatory requirements....RegulatoryFull timeShift work
- ...investigations. Ability to maintain confidentiality and high ethical standards in all aspects of work. Familiarity with legal and regulatory standards related to security and investigations. Multilingual skills are an asset, depending on the regions of operation....RegulatoryTemporary workLocal area
$81.8k - $106.6k
...shape. Job Overview and Responsibilities The Trade Compliance Specialist oversees daily execution of all United trade compliance... ...international borders. The Trade Compliance specialist maintains regulatory awareness of domestic and foreign rulemaking and works with internal...RegulatoryHourly payWork experience placement$84.5k - $162k
...investigations. Ability to maintain confidentiality and high ethical standards in all aspects of work. Familiarity with legal and regulatory standards related to security and investigations. Multilingual skills are an asset, depending on the regions of operation....RegulatoryTemporary workLocal area$84.5k
...investigations. Ability to maintain confidentiality and high ethical standards in all aspects of work. Familiarity with legal and regulatory standards related to security and investigations. Multilingual skills are an asset, depending on the regions of operation....RegulatoryTemporary workLocal area- ...training along with supporting audit documentation requirements for internal Quality, Maintenance Excellence Program (MEP), external regulatory agencies and/or customers.Provide backup assistance and actively cross-train with the MRO II position to ensure seamless...RegulatoryWork at office
- ...verify completeness and reassess MDR reportability decisions.... ...cross-functionally with Quality, Regulatory, Operations, and other teams to... ...identifies reportable events. Support compliance with FDA... ...narratives, product information, and adverse event descriptions to assess...Regulatory
$19.89 - $28.84 per hour
...Interpret physician orders for completeness and compliance with regulatory agencies and NCH policies. Informs patients of registration... ...Certification: Successful on-the-job completion of NCH Patient Access Specialist I competencies required. Benefits (For full time or part...RegulatoryHourly payFull timePart timeFor contractorsWork experience placementWork at officeImmediate startAfternoon shift$19.99 - $22.88 per hour
...Role Summary As an Adventure Readiness Specialist, you are a critical part of the Rivian Service... ...routes, or at community outreach events. Pay Disclosure The hourly range for... ...you; (iv) complying with our legal, regulatory and corporate governance obligations; (v...RegulatoryHourly payFull timeContract workTemporary workPart timeSeasonal workLocal areaFlexible hoursShift work$25.38 - $40.21 per hour
...Full time R49262 C.H. Robinson is looking for a Customs Specialist who will play a critical role in protecting compliance, minimizing... ...service and operational excellence. You will leverage your regulatory expertise and problem-solving skills to support accurate...RegulatoryHourly payFull timeContract workTemporary workWork at officeRemote workWorldwideFlexible hours2 days per week3 days per week- The Sr. Manager, Regulatory Affairs is responsible for leading Rauland's global regulatory... ...while maintaining compliance with FDA, EU MDR, and other international regulatory... ...SaMD), CE Marking, labeling requirements, adverse event reporting, field corrective actions, Declaration...Regulatory
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