- MD Anderson Cancer Center (Houston, TX)
- …will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and applications. They will oversee a team of ... regulatory specialists responsible for advising MD Anderson's investigators on FDA submission requirements and pathways, develop investigational plans and protocols,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior Director of Regulatory Affairs/ Clinical Affairs in ... managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned ANDAs, ...FDA Communications and ANDA status for assigned ANDAs, FDA databases, spreadsheets and communicating to internal stakeholders the… more
- System One (Durham, NC)
- …an experienced QA Consultant to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical Practice (GCP) compliance. The ideal ... of GCP regulations and extensive experience guiding companies through FDA submission readiness, ensuring documentation, processes, and practices meet all… more
- Vanderbilt University Medical Center (Nashville, TN)
- …**Organization:** Director's Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our LDT efforts and ... requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible for a… more
- Texas State University (San Marcos, TX)
- …and guidance from jurisdictions throughout the nation. The role of the FDA Tobacco Compliance Contract Specialist is to assist in the overall administration, ... coordination, training, and monitoring of the FDA Tobacco Compliance Check Program in Texas. The Contract...monthly program eligibility requirements for Contractors, who serve as FDA Inspectors for the program. The Contract Specialist also… more
- Food and Drug Administration (IN)
- …Department of Health and Human Services (DHHS), Food and Drug Administration ( FDA ), Office of the Commissioner (OC), Office of Policy, Legislation, and International ... Economics, responsible for economic, public health, and strategic, cost-benefits analyses of FDA 's policy and rulemaking decisions and to review the economic content… more
- Johns Hopkins University (Baltimore, MD)
- …JHU investigator-sponsor for a specific IND/IDE application prior to submission to the FDA ; issuance of letter of suitability or identification of potential areas ... of JHU IND/IDE sponsors through the initial application process to the FDA and follow-up correspondence including amendments and reporting. Receives and maintains a… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the draft CCDS. + Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as ... if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External Partnerships: + Provide broad and… more
- Envista Holdings Corporation (Pomona, CA)
- …regulatory requirements and corporate standards. This involves assuring quality standards ( FDA , ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device ... duties may be assigned, in addition to those identified below + Ensures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR, MDSAP and Canadian Medical Device… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …to achieve project goals and make vision a reality. Project Description: The FDA is composed of multiple Centers and Offices. Each Center/Office at FDA ... and efficiently support each Center's and Office's mission critical work. The FDA CIO's office, The Office of Digital Transformation (ODT), scope of responsibility… more
- TestPros (Silver Spring, MD)
- …Quality Assurance (QA) Manager to lead our QA efforts in responding to an FDA project. The ideal candidate will have a strong background in regulatory compliance, ... particularly with FDA regulations, and will ensure that all deliverables meet...professionals, and ensuring all products and services comply with FDA requirements. Key Responsibilities: + Oversee the development and… more
- The Hershey Company (Hershey, PA)
- …Classification (HTS) codes (US, CA & MX), Schedule B code for export, FDA and CFIA requirements (product codes and registration information), and Country of Origin ... are critical to avoid delays with Customs and with FDA for shipments that cross a border. The invoice...an accurate detailed description of the product, correct CoO, FDA code, and FDA description (pack out… more
- Cordis (Irvine, CA)
- …strategy development and execution for PMA submissions, ensuring compliance with FDA regulations and guidance. + Collaborate cross-functionally with R&D, Quality ... affairs policies and procedures to enhance operational efficiency. + Help manage FDA IDE/PMA clinical reports/modules and post approval clinical study activities and… more
- Lancaster General Health (Lancaster, PA)
- …Community Blood Drive sites for a safe donation environment, maintenance of FDA requirements, staff assignments and effective workflow for pre-donation, donation and ... are maintained and implemented at all blood collection/manufacturing locations. Responds to FDA or other regulatory agencies when onsite. + Completes LIS computer… more
- BeiGene (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge...and risk assessments, critical issue management and advice on FDA interactions. + Oversees the preparation of NA regulatory… more
- Novo Nordisk (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... and the management of contracts with safety reporting requirements. Key contact person for FDA and Health Canada PV inspections and device inspections as well as key… more
- BeiGene (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... of department policies. **Responsibilities:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically… more
- University of Washington (Seattle, WA)
- …including the Institutional Review Board, the Food and Drug Administration ( FDA ), the Institutional Biosafety Committee, the institutional Radiation Safety Committee ... to the program. **Knowledge, Skills and Abilities** * Expert knowledge of FDA , International Conference on Harmonization, Code of Federal Regulations, and Good… more
- Olympus Corporation of the Americas (San Francisco, CA)
- …the regulatory assessment and submission of Medical Device Reports to the FDA and assisting with submissions to other regulatory agencies worldwide in conformance ... The Manager, Sr. Global MDR Submission communicates with the FDA or other interested internal and external parties as...for preparing and submitting Medical Device Reports to the FDA for all products manufactured or distributed by Olympus… more
- Aerotek (Omaha, NE)
- …In this role, you will operate Tableting machines to manufacture FDA -grade pharmaceutical products. This position requires precision in formulating products using ... mixers, measuring, testing, and ensuring compliance with FDA guidelines. The shift is from 6:00 AM to...+ Measure and test products to ensure compliance with FDA guidelines. + Maintain accurate FDA documentation.… more