- 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 activities.
- Interprets 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.
- Knowledge of regulations and standards affecting IVDs and/or biologics
- Have working knowledge in EU MDR
- Have working knowledge in Regulatory Change Assessments
- Have working knowledge in US and EU medical device submissions
- Work cross-functionally and in a matrixed environment
- Have experience with continuous improvement activities
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Regulatory Specialist I
1 day ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 7 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ras ...
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Regulatory Specialist I
1 week ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 16 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Regulatory Specialist
3 weeks 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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Sr. Regulatory Affairs Specialist
1 week ago
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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Regulatory Affairs Specialist
4 hours ago
ACL Digital Niles, United StatesTHE OPPORTUNITY: · We are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist for a 9 month contract. We are seeking an experienced individual with a strong background in the medical device industry and extensive knowledg ...
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Regulatory Compliance Specialist
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Shelby American Inc Niles, United StatesReporting 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 programs and policies, and serves as su ...
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Regulatory Specialist
4 weeks 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
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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-ar ...
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Regulatory Specialist
2 weeks 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
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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 I
1 week ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 14 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Regulatory Specialist I
4 days ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 11 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Regulatory Specialist I
1 week ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 17 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Regulatory Specialist I
1 week ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 15 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Regulatory Specialist I
5 days ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 12 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Regulatory Specialist I
1 week ago
Collabera Des Plaines, United StatesHome · Search Jobs · Job Description · Regulatory Specialist I · Contract: Des Plaines, Illinois, US · Salary: $38.00 Per Hour · Job Code: · End Date: · Days Left: 18 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Ra ...
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Product Regulatory Compliance Specialist
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Smiths Group Morton Grove, United StatesJob 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 applicable product regulatory compliance requirements. Additionally, this position is respons ...
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Research Regulatory Specialist
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Regulatory Certification Specialist
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Principal Regulatory Affairs Specialist-CT/AMI
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Philips Des Plaines, United StatesThe Principal RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmapsunderstanding competitive claim la ...
Regulatory Specialist I - Des Plaines, United States - Advanced Clinical
Description
OVERVIEW
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 career opportunity.
RESPONSIBILITIES
EXPERIENCE
Must have 1-2 years of experiences in Medical Device Reg Affairs
EDUCATION
BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
To be a best-fit your strengths must include:
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visitRegarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team.
We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application.
In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.