- Serve as primary communication contact for US FDA (CDER, CDRH, CBER etc.)
- Translate and review package inserts and interview forms in English
- Maintain up-to-date knowledge of changes to the regulatory environment in key markets and communicate impactful developments to affected departments
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דף הבית » משרות » Regulatory Affairs Specialist · Regulatory Affairs Specialist · מיקום: · יקנעם · אופן העסקה: · היברידי · תיאור התפקיד: · תפקיד הכולל אחריות על ניהול והובלת תהליכים רגולטוריים גלובליים, כולל הכנת מסמכים, הגשות לרשויות, ותמיכה בעמידה בדרישות התקינה והמדיניות הבינל ...
Ela, IL1 week ago
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Job Overview/Objectives: · This individual will establish regulatory affairs business processes to ensure compliance with all relevant governmental regulatory authorities, with a near term emphasis on US FDA and Japanese regulatory authorities. The categories of supported product ...
Schaumburg $95,000 - $150,000 (USD) per year1 week ago
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Job Overview/Objectives: · This individual will establish regulatory affairs business processes to ensure compliance with all relevant governmental regulatory authorities, with a near term emphasis on US FDA and Japanese regulatory authorities. The categories of supported product ...
Schaumburg $95,000 - $150,000 (USD) per year1 day ago
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Regulatory Affairs Specialist- Medical Devices role at Sunstar Americas, Inc. involves supporting the preparation of regulatory 510(k) submissions and assisting international business partners with product registrations. · BS in Science or Medical / Healthcare related field or hi ...
Schaumburg $66,847 - $100,273 (USD)1 month ago
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Join us and become part of our global team at Sunstar Americas Inc., where together we can achieve success and contribute to a better future. We are seeking a Regulatory Affairs Specialist- Medical Device with experience in the US and Canada regulated industry. · ...
Schaumburg, IL2 months ago
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As a member of the Sunstar Group, Sunstar Americas, Inc., a global organization dedicated to improving overall health through oral health worldwide, holds a prominent position in the oral care industry. Formerly known as the John O. Butler Company, we are renowned for our excepti ...
Schaumburg $83,204 - $124,806 (USD)3 days ago
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At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach ...
Schaumburg, Illinois, United States1 week ago
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The Regulatory Specialist will prepare, amend, and maintain product registration dossiers for all product categories within Milk Quality and Animal Health. The role involves working closely with regulatory colleagues across multiple departments. · Responsible for product registra ...
Des Plaines1 month ago
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WeareseekingaRegulatoryAffairsSpecialisttosupportregulatarysubmissions,globalexceptions,labelingreviews,andcomplianceactivitiesforClassII/IIImedicaldevices.Bachelor'sorMaster'sinEngineering,Regulatory,Biomedical,LifesSciences3–7yearsofRegulatoryAffairsexperiencemedinmedicaldevice ...
Chicago, IL1 month ago
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We are seeking a · Regulatory Affairs Specialist · to support regulatory submissions, · global registrations, · labeling reviews, · and compliance activities for Class II/III medical devices. · ...
Chicago1 month ago
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We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. · Prepare and manage U.S. and global regulatory submissions. · Support execution of global regulatory strategies. · ...
Lake Forest $70,000 - $120,000 (USD) per year2 weeks ago
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Department · PSD Applied Data Science: Instructional Services and Innovation · About the Department · The Master's in Applied Data Science program (MS-ADS) is a professional graduate program within the Physical Sciences Division (PSD) and the Data Science Institute (DSI) at The U ...
Chicago, IL1 week ago
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As a Regulatory Affairs Specialist for Nature's Bakery, you will be responsible for all aspects of ingredient on-boarding, regulatory documentation, regulatory compliance review and third party certification (submissions and managing approvals). You may also play a role in produc ...
Chicago Full time1 month ago
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Department · PSD Applied Data Science: Instructional Services and Innovation · About The Department · The Master's in Applied Data Science program (MS-ADS) is a professional graduate program within the Physical Sciences Division (PSD) and the Data Science Institute (DSI) at The U ...
Chicago $70,000 - $80,000 (USD)1 week ago
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The Medical Affairs Specialist researches and develops documents that support the safety and efficacy of products. · They lead research activities for assigned projects critically evaluating and interpretating scientific data and communicating data impact to assigned products and ...
Vernon Hills $73,300 - $121,000 (USD) Full time3 weeks ago
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The position of Regulatory Affairs Specialist involves managing activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control sections to ensure timely preparation of submission documents. · ...
North Chicago1 month ago
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The Medical Affairs Specialist researches and develops documents that support the safety and efficacy of products. They critically evaluate scientific data and communicate its impact to assigned projects. · ...
Vernon Hills, IL2 weeks ago
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We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. · Provide regulatory support for U.S. and global submissions, including analysis of requirements and tracking deliverablesAssist with executi ...
Lake Forest1 month ago
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Arway–Long Grove Confections was formed through the union of two trusted confectionery companies, combining decades of expertise, quality, and tradition. As a · family-owned business · with roots dating back to 1950, we take pride in crafting high-quality confections and deliveri ...
Chicago, IL $70,000 - $120,000 (USD) per year1 week ago
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Regulatory Affairs Specialist provides active support and assists Regulatory Affairs Manager and other key stakeholders in all regulatory matters to ensure continuous success in attaining business objectives of CJ America Inc. · Job Description and Responsibilities · Assisting R ...
Downers Grove $58,000 - $65,000 (USD)2 weeks ago
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We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. · Prepare and manage U.S. and global regulatory submissions, including FDA and CE technical documentationCollaborate with R&D and global/regional RA partne ...
Lake Forest, IL $70,000 - $120,000 (USD) per year2 weeks ago
Senior Regulatory Affairs Specialist - Schaumburg, IL - Staffing Network LLC
Description
Senior Regulatory Affairs Specialist
This individual will establish regulatory affairs business processes to ensure compliance with all relevant governmental regulatory authorities, focusing on the US FDA and Japanese regulatory bodies. Supported products include IV solutions, drug products under CFR 210 and 211, biologicals, APIs, combination products and medical devices.
Key Responsibilities:
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Regulatory Affairs Specialist
Only for registered members Ela, IL
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Senior Regulatory Affairs Specialist
Only for registered members Schaumburg
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Senior Regulatory Affairs Specialist
Staffing Network LLC- Schaumburg
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Regulatory Affairs Specialist- Medical Devices
Only for registered members Schaumburg
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Specialist, Regulatory Affairs- Medical Device
Only for registered members Schaumburg, IL
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Specialist, Regulatory Affairs- Medical Device
Only for registered members Schaumburg
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Specialist, Regulatory Affairs- Medical Device
Only for registered members Schaumburg, Illinois, United States
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Regulatory Affairs Specialist
Only for registered members Des Plaines
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Regulatory Affairs Specialist
Only for registered members Chicago, IL
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Regulatory Affairs Specialist
Only for registered members Chicago
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Regulatory Affairs Specialist
Only for registered members Lake Forest
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Academic Affairs Specialist
Only for registered members Chicago, IL
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Regulatory Affairs Specialist
Full time Only for registered members Chicago
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Academic Affairs Specialist
Only for registered members Chicago
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Specialist, Medical Affairs
Full time Only for registered members Vernon Hills
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Regulatory Affairs Specialist
Only for registered members North Chicago
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Specialist, Medical Affairs
Only for registered members Vernon Hills, IL
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Regulatory Affairs Specialist
Only for registered members Lake Forest
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Regulatory Affairs Specialist
Only for registered members Chicago, IL
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Regulatory Affairs Specialist
Only for registered members Downers Grove
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Regulatory Affairs Specialist
Only for registered members Lake Forest, IL