Katalyst CRO
Join to apply for the
Senior Regulatory Affairs Specialist
role at
Katalyst CRO Join to apply for the
Senior Regulatory Affairs Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed.
Responsibilities
The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
Requirements
You've acquired 5+ years of experience in the medical device regulatory or quality assurance field. Your skills include knowledge of quality system requirements and FDA and/or international product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K's. Experience with Software is a must. You have a Bachelor's degree in life sciences or a related field. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles. Washington, DC $146,000.00-$218,000.00 1 week ago Washington, DC $124,200.00-$138,000.00 2 weeks ago Sr. Associate Counsel, Global Regulatory Affairs Washington, DC $176,800.00-$230,000.00 1 week ago Corporate Counsel – Transactions & Regulatory AffairsSr Regulatory Affairs Strategy Specialist Washington, DC $92,700.00-$152,900.00 1 week ago Corporate Counsel – Transactions & Regulatory Affairs Washington, DC $123,200.00-$222,200.00 3 weeks ago EHS and Sustainability Regulatory ConsultantCorporate Counsel – Transactions & Regulatory Affairs Herndon, VA $123,200.00-$222,200.00 3 weeks ago Washington, DC $74,100.00-$147,800.00 3 days ago Associate Director Regulatory Affairs Post Marketing Rockville, MD $140,000.00-$175,000.00 4 months ago Data Privacy Regulatory Compliance ConsultantManaging Director, Regulatory & Industry Affairs, Grid Washington, DC $80,000.00-$90,000.00 2 days ago Regulatory Affairs Specialist - Murtha Cancer Center Research Program Bethesda, MD $64,200.00-$109,200.00 3 days ago Regulatory Affairs Examination and Monitoring Lead Associate Washington, DC $121,000.00-$158,000.00 1 day 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
Senior Regulatory Affairs Specialist
role at
Katalyst CRO Join to apply for the
Senior Regulatory Affairs Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed.
Responsibilities
The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
Requirements
You've acquired 5+ years of experience in the medical device regulatory or quality assurance field. Your skills include knowledge of quality system requirements and FDA and/or international product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K's. Experience with Software is a must. You have a Bachelor's degree in life sciences or a related field. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles. Washington, DC $146,000.00-$218,000.00 1 week ago Washington, DC $124,200.00-$138,000.00 2 weeks ago Sr. Associate Counsel, Global Regulatory Affairs Washington, DC $176,800.00-$230,000.00 1 week ago Corporate Counsel – Transactions & Regulatory AffairsSr Regulatory Affairs Strategy Specialist Washington, DC $92,700.00-$152,900.00 1 week ago Corporate Counsel – Transactions & Regulatory Affairs Washington, DC $123,200.00-$222,200.00 3 weeks ago EHS and Sustainability Regulatory ConsultantCorporate Counsel – Transactions & Regulatory Affairs Herndon, VA $123,200.00-$222,200.00 3 weeks ago Washington, DC $74,100.00-$147,800.00 3 days ago Associate Director Regulatory Affairs Post Marketing Rockville, MD $140,000.00-$175,000.00 4 months ago Data Privacy Regulatory Compliance ConsultantManaging Director, Regulatory & Industry Affairs, Grid Washington, DC $80,000.00-$90,000.00 2 days ago Regulatory Affairs Specialist - Murtha Cancer Center Research Program Bethesda, MD $64,200.00-$109,200.00 3 days ago Regulatory Affairs Examination and Monitoring Lead Associate Washington, DC $121,000.00-$158,000.00 1 day 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