Katalyst CRO
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Regulatory Affairs Associate
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Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Associate
role at
Katalyst CRO 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 strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Researches and communicates scientific and regulatory information to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops internal procedures and tools. Conducts informational or training sessions for stakeholders. Organizes and maintains hard copy and electronic department files. Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
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 strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Researches and communicates scientific and regulatory information to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops internal procedures and tools. Conducts informational or training sessions for stakeholders. Organizes and maintains hard copy and electronic department files. Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Requirements:
Bachelor's degree in biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience. 4+ years' experience in Regulatory Affairs role. Strong knowledge of IVDR and EU regulatory requirements is required. Good knowledge of EU and international regulations. Demonstrated written and verbal communication skills. Strong time management skills, with the ability to work on multiple projects simultaneously. Ability to work independently as well as within a team. Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio. Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Associate jobs in
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Regulatory Affairs Associate
role at
Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Associate
role at
Katalyst CRO 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 strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Researches and communicates scientific and regulatory information to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops internal procedures and tools. Conducts informational or training sessions for stakeholders. Organizes and maintains hard copy and electronic department files. Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
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 strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Researches and communicates scientific and regulatory information to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops internal procedures and tools. Conducts informational or training sessions for stakeholders. Organizes and maintains hard copy and electronic department files. Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Requirements:
Bachelor's degree in biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience. 4+ years' experience in Regulatory Affairs role. Strong knowledge of IVDR and EU regulatory requirements is required. Good knowledge of EU and international regulations. Demonstrated written and verbal communication skills. Strong time management skills, with the ability to work on multiple projects simultaneously. Ability to work independently as well as within a team. Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio. Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Associate jobs in
Chicago, IL . Glenview, IL $80,000.00-$95,000.00 1 week ago Regulatory Affairs Specialist- Cosmetic/Drugs
Northfield, IL $79,560.00-$115,440.00 6 days ago Compliance Associate, Financial Regulatory Affairs
Chicago, IL $74,200.00-$126,200.00 6 days ago Compliance Associate, Financial Regulatory Affairs
Chicago, IL $74,200.00-$126,200.00 1 week ago Chicago, IL $54,800.00-$121,100.00 1 week ago Quality Assurance and Regulatory Affairs Manager
Senior Associate, Regulatory Compliance and Governance
Chicago, IL $83,100.00-$141,300.00 1 week ago Niles, IL $75,000.00-$90,000.00 2 weeks ago Senior Scientific & Regulatory Affairs Program Manager - Ingredients and Packaging
Chicago, IL $133,067.00-$182,958.00 2 weeks ago Regulatory Sr. Associate/Sr. Counsel/Jr. Partner
Senior Specialist, Regulatory Affairs (Advertising and Promotion),
Deerfield, IL $80,000.00-$110,000.00 4 days ago Program Manager, Regulatory Affairs, Anesthesia & Respiratory Care
Chicago, IL $103,200.00-$154,800.00 1 week ago Associate Director, Spectrum & Regulatory Affairs
Niles, IL $142,400.00-$242,100.00 5 days ago Senior Specialist, Regulatory Affairs (Advertising and Promotion)
Manager, Regulatory Affairs (Advertising and Promotion)
Deerfield, IL $112,000.00-$155,000.00 1 month ago Senior Associate - Regulatory Compliance (Private Funds)
Chicago, IL $65,000.00-$80,000.00 17 hours ago Chicago, IL $57,000.00-$113,000.00 18 hours ago Clinical Research Associate - Maryland / DC
Clinical Research Associate - Chicago, IL
Clinical Research Associate - Oncology - California (Field Based)
North Township, IN $91,336.00-$114,170.00 1 week ago Clinical Research Associate - Oncology - California (Field Based)
North Township, IN $91,336.00-$114,170.00 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr