Katalyst CRO
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Regulatory Affairs Manager
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Katalyst CRO 2 months ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department. Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams. Document regulatory strategies for product submissions. Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays. Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays. Support EU representatives in their creation of CE/IVD Technical Files. Support global regulatory registration representatives for product registration activities. Perform regulatory assessment of new and changed products. Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment. Assist the Regulatory department in updating, improving, and crafting internal policies and procedures. Participate in business meetings with potential new external partners.
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
Responsibilities
Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department. Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams. Document regulatory strategies for product submissions. Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays. Facilitate FDA pre-submission meetings. Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays. Support EU representatives in their creation of CE/IVD Technical Files. Support global regulatory registration representatives for product registration activities. Perform regulatory assessment of new and changed products. Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment. Assist the Regulatory department in updating, improving, and crafting internal policies and procedures. Participate in business meetings with potential new external partners.
Requirements:
B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science. At least 5 years of IVD Regulatory Affairs experience. Hands-on experience with 510(k), PMA, and PMA supplement submissions. Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements. Experience as the RA representative on project core teams. Strong communication and teamwork skills. Ability to lead multiple projects and meet deadlines. Capacity to communicate regulations to technical functions within the company. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Manager jobs in
Waukegan, IL . Senior Specialist - Regulatory Affairs -Transfusion Evanston, IL $100,000.00-$1,000,000.00 1 month ago Niles, IL $75,000.00-$90,000.00 2 weeks ago Associate Director, Spectrum & Regulatory Affairs Niles, IL $142,400.00-$242,100.00 21 hours ago Senior Specialist, Regulatory Affairs (Advertising and Promotion), Deerfield, IL $80,000.00-$110,000.00 23 minutes ago Niles, IL $115,000.00-$135,000.00 1 month ago Manager, Regulatory Affairs (Advertising and Promotion) Deerfield, IL $112,000.00-$155,000.00 1 month ago Manager, Patient Safety & Regulatory-Centralized FulfillmentSenior Specialist, Regulatory Affairs (Advertising and Promotion)Associate Director, Regulatory Affairs Advertising & Promotion - ImmunologyAssociate Director, Regulatory Affairs Advertising & Promotion - ImmunologySenior Manager RA US Advertising and Promotion - Allergan Aesthetics North Chicago, IL $121,000.00-$230,000.00 4 days ago Senior Manager RA US Advertising and Promotion - Allergan Aesthetics North Chicago, IL $40.00-$50.00 4 days ago Glenview, IL $80,000.00-$95,000.00 4 days ago Regulatory Affairs Specialist- Cosmetic/Drugs Northfield, IL $79,560.00-$115,440.00 1 day ago CMC Regulatory Affairs Associate (Module III)CMC Regulatory Affairs Associate II----HybridRegulatory/Quality Manager-Human NutritionAssociate II, Regulatory Affairs – Regulatory Operations We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Regulatory Affairs Manager
role at
Katalyst CRO 2 months ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department. Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams. Document regulatory strategies for product submissions. Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays. Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays. Support EU representatives in their creation of CE/IVD Technical Files. Support global regulatory registration representatives for product registration activities. Perform regulatory assessment of new and changed products. Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment. Assist the Regulatory department in updating, improving, and crafting internal policies and procedures. Participate in business meetings with potential new external partners.
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
Responsibilities
Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department. Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams. Document regulatory strategies for product submissions. Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays. Facilitate FDA pre-submission meetings. Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays. Support EU representatives in their creation of CE/IVD Technical Files. Support global regulatory registration representatives for product registration activities. Perform regulatory assessment of new and changed products. Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment. Assist the Regulatory department in updating, improving, and crafting internal policies and procedures. Participate in business meetings with potential new external partners.
Requirements:
B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science. At least 5 years of IVD Regulatory Affairs experience. Hands-on experience with 510(k), PMA, and PMA supplement submissions. Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements. Experience as the RA representative on project core teams. Strong communication and teamwork skills. Ability to lead multiple projects and meet deadlines. Capacity to communicate regulations to technical functions within the company. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Manager jobs in
Waukegan, IL . Senior Specialist - Regulatory Affairs -Transfusion Evanston, IL $100,000.00-$1,000,000.00 1 month ago Niles, IL $75,000.00-$90,000.00 2 weeks ago Associate Director, Spectrum & Regulatory Affairs Niles, IL $142,400.00-$242,100.00 21 hours ago Senior Specialist, Regulatory Affairs (Advertising and Promotion), Deerfield, IL $80,000.00-$110,000.00 23 minutes ago Niles, IL $115,000.00-$135,000.00 1 month ago Manager, Regulatory Affairs (Advertising and Promotion) Deerfield, IL $112,000.00-$155,000.00 1 month ago Manager, Patient Safety & Regulatory-Centralized FulfillmentSenior Specialist, Regulatory Affairs (Advertising and Promotion)Associate Director, Regulatory Affairs Advertising & Promotion - ImmunologyAssociate Director, Regulatory Affairs Advertising & Promotion - ImmunologySenior Manager RA US Advertising and Promotion - Allergan Aesthetics North Chicago, IL $121,000.00-$230,000.00 4 days ago Senior Manager RA US Advertising and Promotion - Allergan Aesthetics North Chicago, IL $40.00-$50.00 4 days ago Glenview, IL $80,000.00-$95,000.00 4 days ago Regulatory Affairs Specialist- Cosmetic/Drugs Northfield, IL $79,560.00-$115,440.00 1 day ago CMC Regulatory Affairs Associate (Module III)CMC Regulatory Affairs Associate II----HybridRegulatory/Quality Manager-Human NutritionAssociate II, Regulatory Affairs – Regulatory Operations 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