- University of Pennsylvania (Philadelphia, PA)
- …I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs Specialist-CC 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,… more
- University of Pennsylvania (Philadelphia, PA)
- …Reporting to the Regulatory Affairs New Study & Continuing Review Manager , the Senior Regulatory Affairs Start-Up Specialist will independently prepare and ... oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration… more
- Dartmouth Health (Lebanon, NH)
- …hospital and clinic patient care areas. * Accurately deciphers and implements FDA mandated manufacturer Instructions for Use (IFU). * Determines each medical device ... policy. * Maintains all corresponding medical records for traceability per AAMI, FDA , CDC and Hospital requirements. * Performs all QA requirements (Washer… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …+ Gather, prepare, and maintain appropriate information and documentation per applicable FDA regulations and ICH guidelines (eg, source and case report forms, ... collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally-required guidances. + Able to design and… more
- Lilly (Indianapolis, IN)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation… more
- Terumo Neuro (Aliso Viejo, CA)
- …execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site ... with the protocol, GCP, company SOPs, and all applicable regulations (eg, FDA ). + Understand, read, prepare, and deploy study documentation including, informed… more
- Boehringer Ingelheim (Orlando, FL)
- …specialist role responsible for pull-through of the account plan (developed by the Account Manager ) at the Health System's various sites of care and with the Health ... Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company...Previous account management experience. + Various regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Arena Technical Resources, LLC (Rockville, MD)
- …seeking a Senior Appian Developer in Rockville, MD to join our team supporting the FDA . The Food and Drug Administration ( FDA ) is the federal agency responsible ... food supply, cosmetics, and products that emit radiation. The FDA is also responsible for: advancing the public's health...performance issues, etc. - Work closely with the release manager to ensure completion of key tasks including deployment,… more
- Good Sense Foods (New Hope, MN)
- …leads the sanitation team, monitors work, ensures compliance with regulatory guidelines ( FDA , USDA, SQF, etc.), and works closely with production and quality ... Understand and ensure compliance with all Good Manufacturing Practices (GMPs), HACCP, FDA , USDA, and BRC standards. * Maintain accurate sanitation records, including… more
- Pentax Medical (Montvale, NJ)
- …In this role, the specialist will work under the guidance of a seasoned manager to ensure PENTAX Medical's products for Endoscopes and Speech, Voice and Swallowing ... and manufacture of Speech, Voice and Swallowing products. + Facilitate all FDA registration and listing related activities. + Manage interactions with US Customs… more