Regulatory Affairs Associate
2 weeks ago
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
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Regulatory Affairs Associate
1 month ago
Lake Forest, United States GForce Life Sciences Full timeRegulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...
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Regulatory Affairs Associate
1 month ago
Lake Forest, United States GForce Life Sciences Full timeRegulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...
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Regulatory Affairs Associate
1 month ago
Lake Forest, United States GForce Life Sciences Full timeRegulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...
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Regulatory Affairs Associate
4 weeks ago
Lake Forest, United States PSG Global Solutions Full timeDescription We're looking for a Regulatory Affairs Associate, working in Biotechnology/Medical Devices industry in 100 Abbott Park Road, Lake Forest, Illinois, 60064, United States. Job description: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring...
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Regulatory Affairs Associate Jr
2 weeks ago
Lake Forest, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affairs Associate Jr Contract: Lake Forest, Illinois, US Salary: $27.00 Per Hour Job Code: 348484 End Date: 2024-05-18 Days Left: 3 hours left Apply Job Description: •Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS...
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Regulatory Affairs Associate Jr
2 weeks ago
Lake Forest, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affairs Associate Jr Contract: Lake Forest, Illinois, US Salary: $27.00 Per Hour Job Code: 348484 End Date: 2024-05-18 Days Left: 20 hours left Apply Job Description: •Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS...
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Regulatory Affair Specialist
3 days ago
Lake Forest, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affair Specialist Contract: Lake Forest, Illinois, US Salary: $35.00 Per Hour Job Code: 348942 End Date: 2024-06-01 Days Left: 4 days, 3 hours left Apply Job Description: RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation...
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Regulatory Affairs Specialist
7 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. TERM & START 1-year contract starting 6/10/24 with possibility to extend On-site in Lake Forest, IL (60045) Pay Rate: $30-35/hr depending on...
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Regulatory Affairs Specialist
7 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.TERM & START 1-year contract starting 6/10/24 with possibility to extendOn-site in Lake Forest, IL (60045)Pay Rate: $30-35/hr depending on...
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Regulatory Affairs Specialist
6 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.TERM & START 1-year contract starting 6/10/24 with possibility to extendOn-site in Lake Forest, IL (60045)Pay Rate: $30-35/hr depending on...
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Regulatory Affairs Specialist
6 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.TERM & START 1-year contract starting 6/10/24 with possibility to extendOn-site in Lake Forest, IL (60045)Pay Rate: $30-35/hr depending on...
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Regulatory Affairs Associate
5 days ago
Lake Forest, United States PSG Global Solutions Careers Full timeApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Regulatory Affairs Associate, working in Biotechnology/Medical Devices industry in 100 Abbott Park Road, Lake Forest, Illinois, 60064, United States. Job description: Responsible for filing necessary applications and...
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Regulatory Affairs Specialist
3 weeks ago
Lake Forest, United States INTELLECTT INC Full timeRole: Regulatory Specialist II Location: Lake Forest, IL, Santa Clara, CA, Boston, MA Duration: 6-12 Months RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops...
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Regulatory Affairs Specialist
2 weeks ago
Lake Forest, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months RESPONSIBILITIES:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory...
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Regulatory Affairs Specialist
3 weeks ago
Lake Forest, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months RESPONSIBILITIES:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory...
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Regulatory Affairs Specialist
3 weeks ago
Lake Forest, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months RESPONSIBILITIES:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory...
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Regulatory Affairs Specialist
1 week ago
Lake Forest, United States INTELLECTT INC Full timeRole: Regulatory Specialist II Location: Lake Forest, IL, Santa Clara, CA, Boston, MA Duration: 6-12 Months RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops...
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Regulatory Affairs Specialist II
18 hours ago
Lake Forest, United States DivIHN Integration Full timeDivIHN (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...
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Regulatory Compliance
7 days ago
Lake Forest, United States Beacon Hill Full timeJob DescriptionYour Role: As a Regulatory Contractor, you will learn how a Consumer packaged goods (CPG) company stays compliant with the many regulations, Federal, State, and International, which affect its business. You will have the opportunity to:Gather necessary information from new suppliers to meet Reynolds regulatory requirements.Work on updating the...
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Regulatory Specialist II
4 weeks ago
Lake Forest, United States Collabera Full timeJob DescriptionJob Description· The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. · In this role you will prepare documentation for EU Technical Files and international product registrations. · This job description will be reviewed periodically and is...