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Regulatory Specialist
4 days ago
PLZ Corp Downers Grove, United StatesPLZ is committed to product stewardship and innovation, strong ethical standards, sustainable operations and most importantly, the development of our people. Whether at our manufacturing facilities or corporate headquarters, PLZ prioritizes health and safety, and offers you the s ...
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Product Regulatory Compliance Specialist
4 hours ago
Smiths Group Morton Grove, United StatesREF: · - JOHNCRANENA01937- DIVISION: · - John Crane- JOB FUNCTION: · - Engineering**Job Description**: · - This position reports directly to the Global Product Regulatory Compliance Program Manager and is responsible for ensuring that all John Crane products are compliant with ap ...
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Product Regulatory Compliance Specialist
1 week ago
John Crane Morton Grove, United StatesThis position reports directly to the Global Product Regulatory Compliance Program Manager and is responsible for ensuring that all John Crane products are compliant with applicable product regulatory compliance requirements. Additionally, this position is responsible for ensurin ...
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Regulatory Affairs Specialist
2 days 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 Specialist I
1 week ago
Advanced Clinical Des Plaines, United StatesOVERVIEW · We are currently searching for a skilled professional to join a well-known client's team as a Regulatory Specialist in Des Plaines, IL. The Regulatory Specialist role will have a direct impact on the organization and the larger clinical industry, making this an amazing ...
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Regulatory Affairs Specialist
1 week ago
ProKatchers Des Plaines, United StatesJob Title: Regulatory Affairs Specialist · Location: Des Plaines, Illinois, United States · Duration: 08 Months · Job Description: · Description: · Must have 1-2 years of experiences in Medical Device Reg Affairs · Have working knowledge in EU MDR Have working knowledge in ...
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Regulatory Affairs Specialist
2 weeks ago
ProKatchers LLC Des Plaines, United StatesJob Title: Regulatory Affairs Specialist · Location: Des Plaines, Illinois, United States · Duration: 08 Months · Job Description: · Description: · Must have 1-2 years of experiences in Medical Device Reg Affairs · Have working knowledge in EU MDR Have working knowledge in Regul ...
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Regulatory Research Specialist
1 week ago
Ascension Lisle, United StatesWe Are Hiring: · - **Department**: Research · - ** Schedule**: Full Time, Day Shifts · - ** Hospital**: Ascension Alexian Brothers · - ** Location**:Elk Grove Village, Illinois · What You Will Do: · Create and submit all required regulatory submissions related to research studies ...
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Research Regulatory Specialist
23 hours ago
Advocate Aurora Health Park Ridge, United StatesMajor Responsibilities:Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies. Plans, develops an Regulatory, Specialist, Clini ...
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Regulatory Risk Managment Specialist
1 week ago
Northern Trust Corp. Chicago, United StatesAbout Northern Trust: · Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. · Northern Trust is proud to provide innovative financial services and guidance to the world's most succe ...
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Research Regulatory Specialist
5 days ago
Advocate Health Park Ridge, United StatesMajor Responsibilities · Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies. · Plans, develops and prepares all required r ...
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Regulatory Compliance Specialist
1 week ago
Greenwood Associates Niles, United StatesJob Type · Full-time · Description · Reporting to the Food Safety, Quality, and Regulatory Manager, the Regulatory Compliance Specialist is responsible for maintaining the effective and consistent operation, verification, and current compliance of our organization's regulatory ...
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Regulatory Specialist
6 days ago
Sterling Engineering Skokie, United StatesROLE SUMMARY: · The Regulatory Specialist plays a crucial role in supporting internal and external stakeholders regarding regulatory matters. This position involves managing and prioritizing customer needs and requests related to specifications, questionnaires, labeling, kosher, ...
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Regulatory Specialist
1 week ago
Georgia Nut CO Skokie, United StatesJob Details · Job Location · Skokie, IL - Skokie, IL · Remote Type · Hybrid · Position Type · Full Time · Job Shift · First Shift · Description · COMPANY OVERVIEW · Georgia Nut Company (GNC) is a food manufacturing company that combines classic recipes with state-of-the- ...
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Regulatory Specialist
1 week ago
Sterling Engineering Skokie, United StatesJob Description · Title: Regulatory Specialist · Location: Skokie, IL · Overview: · Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provid ...
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Regulatory Specialist
3 days ago
Aegis Worldwide Skokie, United StatesJob Description Job Description Aegis Worldwide is partnered with a leading food manufacturer who is seeking a Regulatory Specialist. You will have the ability to be a part of a extremely stable company with a relaxed and autonomous environment. Also, it will be a basic 8-5 sched ...
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Regulatory Specialist
5 days ago
Sterling Engineering Inc. Skokie, United StatesJob Description · Job DescriptionTitle: Regulatory Specialist · Location: Skokie, IL · Overview:Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterl ...
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Regulatory Specialist
1 week ago
Aegis Worldwide Lincolnwood, United StatesJob Description · Job DescriptionWe are seeking a Regulatory Specialist to join the team at a food manufacturing company. This role reports directly to the Regulatory Manager. · Responsibilities: · The Regulatory Specialist is responsible for supporting both internal partners an ...
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Regulatory Specialist
1 week ago
Aegis Worldwide Lincolnwood, United StatesJob Description · Job DescriptionWe are seeking a Regulatory Specialist to join the team at a food manufacturing company. This role reports directly to the Regulatory Manager. · Responsibilities: · The Regulatory Specialist is responsible for supporting both internal partners an ...
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Regulatory Specialist
1 week ago
Aegis Worldwide Lincolnwood, United StatesJob Description · Job DescriptionWe are seeking a Regulatory Specialist to join the team at a food manufacturing company. This role reports directly to the Regulatory Manager. · Responsibilities: · The Regulatory Specialist is responsible for supporting both internal partners an ...
Regulatory Specialist I - Des Plaines, United States - DivIHN Integration
Description
DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm.Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations.
Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at to learn more and view our open positions.Please apply or call one of us to learn moreFor further inquiries regarding the following opportunity, please contact our Talent SpecialistsMeghna | Title:
Regulatory Specialist ILocation:
Des Plaines, ILDuration: 8 MonthsDescription:Exempt/
Non Exempt:
Non Exempt
Years Experience:0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs functionMust have 1-2 years of experiences in Medical Device Reg AffairsSkills:Knowledge of regulations and standards affecting IVDs and/or biologicsHave working knowledge in EU MDRHave working knowledge in Regulatory Change AssessmentsHave working knowledge in US and EU medical device submissionsWork cross-functionally and in a matrixed environmentHave experience with continuous improvement activitiesEducation:BA Degree RequiredBS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etcDuties:Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.Provides consultation/advice to regulatory specialist for change control and product development.
Provides regulatory direction/interpretation on team terprets and applies regulatory understanding to support of products and teams.
Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
Handles regulatory activities involved in documentation,labeling,field support.
Applies regulatory and technical knowledge to a wide variety of complex work assignments.
Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.Assist the strategy implementation and operations for regulatory affairs activities, including preparing documents and deliverables to supporting change notifications and submission activities , license renewals etc.
Working knowledge of the regulations including EU MDR would be helpful in understanding the regulatory requirements for IVDR implementation.Identify opportunity for regulatory affair processes and drive changes to completion.
This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
Additionally Provide tracking, reporting, and presentation to management for the project activities.
About us:
DivIHN, the IT Asset Performance Services organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.
DivIHN is an equal opportunity employer.
DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
