- 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
- Must have 1-2 years of experiences in Medical Device Reg Affairs
- 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
- BA Degree Required
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc
- 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.
- 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.
-
Regulatory Affairs Specialist
Found in: Appcast Linkedin GBL C2 - 1 day 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 ...
-
Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 6 days 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 ...
-
Regulatory Specialist I
Found in: Lensa US 4 C2 - 1 day ago
DivIHN Integration Des Plaines, United StatesDivIHN (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 200 ...
-
Sr. Regulatory Specialist
Found in: Lensa US 4 C2 - 3 days ago
ZeroWater Des Plaines, United StatesPosition: Product Regulatory Specialist II · Supervisor: Manager, Product Compliance & Regulatory Affairs · Location:Rosemont, IL / Hybrid · Responsibilities: The Snr Product Regulatory Specialist is responsible for obtaining registrations and certification approvals for new a ...
-
Regulatory Compliance Specialist
Found in: Lensa US 4 C2 - 5 days 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 ...
-
Regulatory Specialist
Found in: Appcast Linkedin GBL C2 - 4 hours 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, ...
-
Regulatory Specialist
Found in: Lensa US 4 C2 - 5 days 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 ...
-
Regulatory Specialist
Found in: Lensa US 4 C2 - 3 days 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- ...
-
Regulatory Specialist
Found in: ZipRecruiter Test10S US C2 - 2 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 ...
-
Regulatory Specialist
Found in: ZipRecruiter Standard US C2 - 1 day 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
Found in: Lensa US 4 C2 - 3 days ago
Agility Personnel Skokie, United StatesJob Description · Job Description · PRIMARY RESPONSIBILITIES · Manage review and approval of new ingredient documentation from suppliers and any updated documentation according to established frequency. · Populate regulatory/ labeling information in customer portals or questio ...
-
Regulatory Specialist
Found in: ZipRecruiter Test10S US C2 - 2 days ago
Agility Personnel Skokie, United StatesJob Description · Job DescriptionPRIMARY RESPONSIBILITIES · Manage review and approval of new ingredient documentation from suppliers and any updated documentation according to established frequency. · Populate regulatory/ labeling information in customer portals or questionnaire ...
-
Sr. Regulatory Affairs Specialist-CT/AMI
Found in: Lensa US 4 C2 - 3 days ago
Philips Des Plaines, United StatesThe Senior 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 roadmaps—understanding competitive claim land ...
-
Regulatory Compliance Specialist
Found in: Lensa US 4 C2 - 2 days ago
Bell Flavors & Fragrances Northbrook, United StatesNorthbrook, IL · Join Our Flavorful Team as a Regulatory Compliance Specialist · Are you passionate about ensuring that every bite and sip meets the highest quality and safety standards? Do you thrive in an environment where precision and compliance are key ingredients? If so, ...
-
Regulatory Specialist
Found in: Appcast US C2 - 2 days ago
Viva USA, Inc. Lake Forest, United StatesTitle: Regulatory Specialist - Onsite · Description: · Years Experience: · 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function · Skills: · Knowledge of regulations ...
-
Regulatory Specialist
Found in: Lensa US 4 C2 - 6 hours ago
Viva Usa, Inc. Lake Forest, United StatesTitle: Regulatory Specialist - Onsite Description: Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards ...
-
Regulatory Specialist
Found in: Lensa US 4 C2 - 10 hours ago
MashPoint Chicago, United StatesPosition- · Regulatory Specialist · Duration- 6 months (Possible extension) · Location: Chicago, IL Hybrid (50 Remote / 50 onsite) · Position Summary · As a Scientific & Regulatory Affairs (SRA) member, the incumbent is responsible for screening, tracking, and maintaining re ...
-
Regulatory Specialist
Found in: Lensa US 4 C2 - 5 days ago
PLZ Aeroscience 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 ...
-
Regulatory Specialist
Found in: Lensa US 4 C2 - 3 days ago
OSI Group Aurora, United StatesJob Description · This role is responsible for support in implementing new food regulation and laws that impact OSI products. Collecting and analyzing ingredient specifications is vital in ensuring OSI is complaint to upcoming food regulations. Regulatory specialist will need to ...
-
Regulatory Specialist
Found in: One Red Cent US C2 - 3 days ago
OSI Group Aurora, United StatesJob DescriptionThis role will onboard new products from idealization to production. This role will also need to communicate with R&D, sales, production, FDA, USDA and ingredient suppliers to retrieve key information to support decisions involving labeling, claims, exporting compl ...
Regulatory Specialist I - Des Plaines, United States - DivIHN Integration Inc
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 more
For further inquiries regarding the following opportunity, please contact our Talent Specialists
Meghna
Title: Regulatory Specialist I
Location: Des Plaines, IL
Duration: 8 Months
Description:
Exempt/Non Exempt: Non Exempt
Years Experience:
Skills:
Education:
Duties:
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. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
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.
