- UTMB Health (Galveston, TX)
- …Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point ... and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize...regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory… more
- CVS Health (Blue Bell, PA)
- …the US public health in collaboration with Food and Drug Administration ( FDA ), academic institutions, and other health insurance companies. The SS&C team conducts ... medical chart review validations, and pragmatic research using the FDA Sentinel Common Data Model (SCDM), Sentinel and Distributed...large datasets from multiple sources + Experience with the FDA on research initiatives and data driven projects +… more
- University of Maryland, Baltimore (Baltimore, MD)
- …the radiopharmacist and RDRC investigators so that their reports are in alignment with FDA annual reporting requirements. . Manage all interactions with the FDA , ... including annual reports, special summaries, FDA inspections. . Keep abreast of Code of Federal Regulations (Title 21 | 361.1) governing RDRCs. . Represent RDRC to the University's Radiation Safety Committee. *_SKILLS AND QUALIFICATIONS_* The successful… 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 ... devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for: advancing the public's health by helping to speed… more
- Lilly (Boston, MA)
- …Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports ... (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory...to regulatory scientists. + Participate in face-to-face meetings with FDA , EMEA and other regulatory bodies + Participate in… more
- ABM Industries (Irvine, CA)
- …the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. Understands and is aware of the quality ... Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part 11, and ISO 13485. Maintain working knowledge… more
- Oracle (Augusta, ME)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Oracle (Helena, MT)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Unither Pharmaceuticals (Rochester, NY)
- …necessary controls and mitigation methods. Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance as well as ... change and adapt project scope creep and change in timelines. Understanding of FDA requirements for validation. The ability to analyze and interpret data. In depth… more
- Katecho (Des Moines, IA)
- …System (QMS), ensuring alignment with both internal and external standards, including FDA , EMA, ICH, and GMP. + Regulatory Compliance: Ensure compliance with ... applicable pharmaceutical regulations ( FDA , EMA, ICH, etc.) and work closely with regulatory agencies during audits, inspections, and submissions. + Quality Control… more