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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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This position is PHMSA's Supervisory Attorney-Advisor for Regulatory Affairs Law/Office of Chief Counsel, with comprehensive responsibility for the direct supervision of staff as the Deputy Assistant Chief Counsel for Regulatory Affairs.
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
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Director, CMC Regulatory Affairs – BiologicsKEY RESPONSIBILITIESThe Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.
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Our client is seeking a Regulatory Affairs Manager for the Murtha Cancer Center Research Program (MCCRP), Uniformed Services University of the Health Sciences (USUHS) and John P. Murtha Cancer Center (MCC) at the Walter Reed National Military Medical Center in Bethesda, Maryland.
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A minimum of 10 years of experience in Regulatory Affairs, CMC Biologics (Bachelor's degree requires at least 12 years) Work with VP of Regulatory Affairs to identify resource needs, including consultants and new associates, advising on skills sets to meet needs.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Principal Regulatory Affairs Specialist. 7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent experience. Propose solutions for Regulatory Affairs questions/issues to RA management.
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Monitor changes in relevant regulatory areas and provide education on those changes to business and operational personnel and compliance and legal affairs teams. We employ more than 28,000 people who work in inpatient and outpatient clinical care, research, and graduate medical education as well as critical supporting roles in administration, information technology and informatics, finance, legal and community affairs, communications and marketing, fund-raising, groundskeeping and facilities, and many more.
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We are specifically wanting someone to join our team as a Sr. Regulatory Affairs/Safety Officer Specialist. A Regulatory Affairs/Safety Officer Specialist ensures compliance with all OSHA requirements, supports GMP compliance activities by participating in audits, preparing for regulatory inspections, reviewing procedures, and maintaining error-reporting systems.
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Organization: OLA (Legal Affairs) 10 Job Summary: Vanderbilt Health - Executive Search Team is conducting a national search for a Division Counsel - Compliance & Regulatory Attorney with a strong regulatory and compliance background, including expertise in federal and state fraud, waste and abuse laws and related regulations, Medicare and Medicaid (TennCare) regulations and conditions of participation, and clinical research compliance.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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regulatory affairs jobs Title: sr director Company: Jobot
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