MDR & Regulatory Reporting Specialist
Medline Industries, Inc. in
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, and R&D. The position requires a bachelor's degree and 1+ year of relevant experience in regulated environments. The company offers a comprehensive benefits package and opportunities for growth within a large, global organization. #J-18808-Ljbffr Medline Industries, Inc. in
- ...Medline in Mundelein, IL is seeking an Adverse Event Specialist to manage product complaint remediation and MDR reporting responsibilities. The role requires applying... ...historical and new complaints, determine regulatory obligations, and submit MDRs via the FDA eMDR portal...Suggested
- ...in Mundelein, IL is seeking an Adverse Event Specialist responsible for product complaint remediation and MDR reporting in compliance with FDA requirements. You will... ...submissions via eMDR, while coordinating with Quality, Regulatory Affairs, and R&D to gather needed information....Suggested
- ...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... ...the FDA eMDR portal, collaborating with Quality, Regulatory Affairs, R&D, and Operations to gather required...Suggested
- A reputable law firm in Vernon Hills is seeking a Controls Specialist to support the execution and improvement of internal control reporting. The role involves maintaining control documentation, conducting testing, and ensuring compliance with regulations. Responsibilities...SuggestedWork at office
- ..., X and YouTube. Job Description The primary objective of this position is to lead the planning, forecasting, and reporting of key Global and US Therapeutics SG&A and distribution margin expense budgets. This role will also be responsible for leading the...SuggestedFull timeWork experience placementLocal area
- Medline Industries, LP is seeking an Adverse Events Specialist to review product complaints and determine MDR reportability under FDA regulations. You will ensure that... ...will work cross‑functionally with Quality, Regulatory Affairs, R&D, Operations, and other partners to...
- ...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...
- Medline is seeking an Adverse Event Specialist in Mundelein, IL. The role focuses on reviewing... ...product complaints to determine MDR reportability under FDA regulations (21 CFR 803) and... ...experience in complaint handling or regulatory affairs. It is a hybrid role with salary...
- 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...
- Overview Seeking contingent workers to support Medical Device Reporting (MDR) remediation activities, with a focus on retrospective... ...within complaint records and work cross‑functionally (Quality, Regulatory, Operations, etc.) to obtain necessary information for a defensible...
$35 per hour
...Medical Device Quality and Compliance Specialist Job Description As a Medical Device... ...responsible for handling complaints, conducting MDR reportability assessments, supporting post-market... ...-functionally with teams in Quality, Regulatory Affairs, Clinical, R&D, Operations,...Contract workTemporary workWork at office$93.5k - $114.4k
...worldwide. Description of Job: The Trade Compliance Specialist is responsible for supporting and maintaining the organization... ..., customs compliance activities, broker management, and regulatory reporting. The position partners closely with logistics, procurement,...Full timeWork at officeImmediate startWorldwideFlexible hours$61.3k - $122.7k
...scientists. The Opportunity The Regulatory Affairs Specialist II (Medical Events) position supports... ...documentation, and submission of Medical Device Reports (MDRs), including international... ...information needed to determine MDR and/or Vigilance reportability. Interact...Full timeWorldwideShift work- ...assess incoming complaints and hazards, assist in post-market reportability determinations, and provide clinical resource support to... ...reporting, and conducting risk analyses to inform design changes and regulatory compliance. #J-18808-Ljbffr Medline Industries, Inc.
- ...collaborative, hands-on Accounting Manager to lead our accounting team within Operations. The role oversees accounting operations, financial reporting, payroll, and budgeting in a hybrid Vernon Hills office. You will partner with senior leadership, support month-end close, and...Work at office
- ...focus on retrospective complaint review reportability assessments under FDA requirements. Roles... ...to verify completeness and reassess MDR reportability decisions. Apply current... ...work cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary...
- ...on LinkedIn, Facebook , Instagram , X and YouTube. Job Description This role oversees balance sheet forecasting and reporting responsibilities for US Therapeutics, Global DSO reporting, Global intangibles testing, as well as supporting our SOX program and...Full timeContract workWork experience placementLocal area
$68k - $136k
...revolutionizing the way people monitor their glucose levels with our new sensing technology. The Opportunity We are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Buffalo Grove, IL. We’re focused on helping people with diabetes manage their health...WorldwideShift work- ...day for compliance monitoring, field surveys, and client and regulatory agency meetings. Peak construction occurs roughly between June... ...compliance monitoring staff, their schedules, duties, and project reporting. ~ Working with WRA team leaders, project managers, and...Full timePart timeSecond jobWork at officeLocal areaFlexible hoursShift workNight shift
$142.63k - $208.5k
...timing, uptake curves, market share, probability of technical & regulatory success, & risk adjustments to be included in the forecasting... ...developing forecasting with the following financial modeling, reporting & presentation tools: Excel, BPC, PowerPoint & Power BI. Work...Full timeTemporary workWork experience placementRemote workWork from homeShift work3 days per week- ...for licensing arrangements across Therapeutics, Aesthetics, Legal, Tax, and R&D Finance. You will ensure timely royalty processing, reporting, and strong financial stewardship, partnering with Alliance Management and external partners. The role requires 7-10 years in...
- Pioneer Data Systems, Inc is seeking a Regulatory Specialist to ensure compliance in recipes and labeling processes. This role involves supporting the Regulatory Affairs team as they transition away from artificial ingredients. The ideal candidate will assist with ingredient...
- ...damage. Gather evidence, interview witnesses, and prepare incident reports. Coordinate with Risk department on insurance claim items.... ...and conduct ongoing safety training for existing staff. Regulatory Compliance: Ensure compliance with applicable occupational health...Work at officeLocal areaRemote workMonday to FridayFlexible hours
- ...maintain attention to detail in fast-paced environments.Preferred Skills & Qualifications:Familiarity with Tableau or Power BI for reporting and dashboard visualization.Experience in asset management and compliance reporting.Exposure to automation or log analysis tools...
- ...support HIPAA privacy and security activities, and assist with regulatory monitoring. This role ensures adherence to all federal and... ...up on corrective action items. Prepare routine compliance reports, dashboards, and status updates for review by the Compliance Committee...Weekly payWork at office
$55.64k - $92.73k
...ESSENTIAL FUNCTIONS: Ensures compliance with all state and federal regulatory requirements including, but not limited to, Anti-Money... ...questions and processes account transactions Develops and reviews reports to audit fiduciary transactions, including tax reporting...Local area$160k - $180k
...LaSalle Network is hiring for a Senior Manager, External Reporting with an industry leading home, security, and digital products client. This is a highly visible, corporate accounting role supporting a public company environment. The successful candidate will be responsible...Permanent employmentFull timeContract work$56k - $85k
Job Description The Trade Compliance Specialist works as an integral member of the Fortune Brands Innovations Customs team. This role will... ...Location: This role is eligible for a hybrid work schedule, reporting to the Deerfield HQ Tues-Thurs, with the option to work...Remote workMonday to FridayFlexible hours$120k
...and maintain the bank’s compliance programs. Conduct regular risk assessments and compliance audits. Monitor and report on compliance with regulatory requirements. Provide guidance and training to business units on compliance matters. Investigate and resolve compliance...$151.9k - $173.4k
...accuracy and adherence to test procedures; Evaluate Internal Audit, Regulatory Exam, and self identified issues and events for compliance... ...maintenance of the Compliance Program, such as how to monitor, report, and train; Support lines of business through expert advice,...Full timePart timeLocal area
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