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Regulatory Affairs Specialist
2 weeks ago
McCain Foods USA, Inc. Oakbrook Terrace, United States**Position Title**:Regulatory Affairs Specialist · **Position Type**: Regular - Full-Time · **Position Location**:Oakbrook Terrace · **Requisition ID**: 28326 · The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished g ...
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Regulatory Affairs Specialist
2 weeks ago
Northwestern Medicine Chicago, United StatesBenefits · $10,000 Tuition Reimbursement per year ($5,700 part-time) · $10,000 Student Loan Repayment ($5,000 part-time) · $1,000 Professional Development per year ($500 part-time) · $250 Wellbeing Fund per year($125 for part-time) · Annual Employee Merit Increase and Incent ...
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Regulatory Affairs Specialist
5 days ago
Medline Industries Winnetka, United StatesJOB SUMMARY: · Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch market ...
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Regulatory Affairs Specialist
3 weeks ago
Medline Industries Winnetka, United StatesJOB SUMMARY: · Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch market ...
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Regulatory Affairs Specialist
3 weeks ago
Northwestern Medicine Chicago, United StatesBenefits · $10,000 Tuition Reimbursement per year ($5,700 part-time) · $10,000 Student Loan Repayment ($5,000 part-time) · $1,000 Professional Development per year ($500 part-time) · $250 Wellbeing Fund per year($125 for part-time) · Annual Employee Merit Increase and Incentive B ...
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Regulatory Affairs Specialist
3 weeks ago
Northwestern Medicine Chicago, United StatesBenefits$10,000 Tuition Reimbursement per year ($5,700 part-time)$10,000 Student Loan Repayment ($5,000 part-time)$1,000 Professional Development per year ($500 part-time)$250 Wellbeing Fund per year($125 for part-time)Annual Employee Merit Increase and Incentive BonusPaid time o ...
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Public Affairs Specialist
3 weeks ago
Metropolitan Water Reclamation District of Greater Chicago Chicago, United StatesGeneral Statement · Under direction, performs a variety of public information assignments including developing and writing press releases, talking points, presentations, fact sheets, and social media messages, and graphic design. · Essential Job Functions · Essential job functi ...
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Regulatory Compliance Specialist
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Dr. Oetker Naperville, United States**Regulatory Compliance Specialist** · **Compliance | Naperville | Full Time | Permanent** · Wilton is a US heritage brand with a 95-year history in baking and decorating. Now fully integrated into the Dr. Oetker family, Wilton aspires to be the most influential and successful ca ...
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Regulatory Affairs Specialist, Cosmetics
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Sr. Regulatory Affairs Specialist
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Abbott Des Plaines, United StatesJob Description · Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and bra ...
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Senior Public Affairs Specialist
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Metropolitan Water Reclamation District of Greater Chicago Chicago, United StatesGeneral Statement · Under direction, assists in the development and administration of the District's communication strategy and organizational branding efforts. Essential Job Functions · Essential job functions are fundamental, core functions common to positions in a classifi ...
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Senior Public Affairs Specialist
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Metropolitan Water Reclamation District of Greater Chicago Chicago, United StatesGeneral Statement · Under direction, assists in the development and administration of the District's communication strategy and organizational branding efforts. Essential Job Functions · Essential job functions are fundamental, core functions common to positions in a classifi ...
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Senior Specialist Public Affairs
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Regulatory Specialist I
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Ecolab Naperville, United States**R Regulatory Specialist I (Open)** · The Regulatory Affairs team helps ensure that what we sell is imported and sold in accordance with local regulations. We work closely with government and trade associations to ensure the changing regulatory landscape benefits consumers and o ...
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Associate Regulatory Affairs Specialist
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Medline Industries Winnetka, United StatesJOB SUMMARY: · Under direct supervision, responsible for executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare and review documents for regulatory filings for regulatory authorities under general supervision of RA management ...
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Associate Regulatory Affairs Specialist
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Medline Industries Winnetka, United StatesJOB SUMMARY: · Under direct supervision, responsible for executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare and review documents for regulatory filings for regulatory authorities under general supervision of RA management ...
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Senior Specialist Public Affairs
6 days ago
Abbott Laboratories Chicago, United States Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Senior Specialist Public Affairs
3 weeks ago
Abbott Laboratories Chicago, United States Full timeWorking at Abbott · At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: · Career development with an international company where you can grow the career you dream of . · Free m ...
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Administrative Assistant V
1 week ago
College of DuPage Glen Ellyn, United States**Administrative Assistant V (FT), CFRN20585CE** · **Administrative Assistant V (FT), CFRN20585CE** · The College of DuPage is a comprehensive community college located 27 miles west of downtown Chicago, vitally connected to our local area for over 50 years. We prepare students f ...
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Associate Vice President for Student Success
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Garrett Evangelical The Evanston, United StatesThe Office of Academic Affairs engages the entire Garrett community in realizing the excellence and integrity of the educational mission of the institution. The unit incorporates faculty life and curriculum development, student affairs, library services, tutoring and writing supp ...
Regulatory Affairs Specialist - Warrenville, United States - Performance Health
2 weeks ago
Description
Performance Health is seeking a Regulatory Affairs Specialist to join our team.This role is responsible for establishing & maintaining global regulatory registrations & listings, ensuring products & associated documentation/labeling are in compliance with applicable regulations, and performing proactive regulatory intelligence to identify & implement action plans to ensure timely compliance with upcoming regulatory changes.
This is a hybrid position working 1-2 days per week in our corporate office in Warrenville, IL.Essential Job Duties & ResponsibilitiesMaintain global establishment & medical device, drug, & cosmetic registrations & listings Ensure product labeling claims are accurate, substantiated, documented, & compliant with applicable regulationsAssist with the creation & maintenance of EU Declaration of Conformities and Technical FilesAssist with the creation of Post Market Surveillance reports and Clinical Evaluation ReportsInteract with EU & Swiss Authorized Representatives as requestedProvide support for medical device and drug classification in global marketsAssist with global regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug productsPrepare and maintain global regulatory documents and activities required to secure global licenses, registrations and listings in a timely and cost-effective manner such as legalization/apostille of documents and CFGs.
Assist with the investigation and reporting to global regulatory authorities of product complaints that either have, or may result in serious injury Monitor domestic and international regulatory developments changes that may potentially impact the company's products and operations, and provide proactive interpretative analysis of regulations, directives and guidance for required actionsProvide education and training on regulations to company employees, as neededPerforms other duties as assigned Job Qualifications Bachelor's degree in Pharmaceutical, Life Sciences, Engineering or other related technical fieldMinimum of 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugsProven experience building effective relationship with the FDA and other international regulatory bodies including the EU and Health CanadaExperience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodiesStrong knowledge of global country specific regulations required for registering and marketing products for sale in applicable countriesUnderstanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standardsAbility to travel up to 10% of the time, including overnight travel BenefitsOur benefits include healthcare; insurance benefits; retirement programs; paid time off plans; family and parentingWith one click and a connection to
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