- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- LiDestri (Fairport, NY)
- …development files, process deviation files, and regulatory process filing files for regulatory compliance; Filing with FDA and California as needed + Report ... requirements + Support the submission of processes to the FDA via website + Hands on preparation and communication...food safety & quality problems to personnel with authority to initiate action… more
- University of Miami (Miami, FL)
- …the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks proposals and other study ... of clinical research coordinators (CRCs), ensuring efficient workload distribution and high- quality research operations. This role will involve closely analyzing the… more
- Zimmer Biomet (Austin, TX)
- …feasibility studies, prototyping, and design optimization + You will partner with Quality , Regulatory , and Clinical teams to ensure design compliance with ... FDA , ISO 13485, and other global regulatory ...fast-paced, cross-functional environment + Commitment to patient safety, product quality , and regulatory compliance + Strategic and… more
- Bausch + Lomb (Kirkwood, MO)
- …the quality and manufacturability of the PCB and cable designs, regulatory compliance and high- quality execution across multiple programs. The ideal ... Coordinate with external partners, suppliers, and contract manufacturers when needed. + Support regulatory submissions (eg, FDA 510(k), PMA) and audits as the… more
- Merck (North Wales, PA)
- …questions for FDA edata mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA). + Guide project teams preparing submission ... **Job Description** **Responsibilities:** + Provide oversight and quality management of submission data standard deliverables for world-wide regulatory … more
- Sanofi Group (Cambridge, MA)
- …part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- BeOne Medicines (Emeryville, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
- Dartmouth Health (Lebanon, NH)
- …development. Responsibilities * Interprets and applies federal (US, EMA, or other) regulatory laws and guidance when conducting quality assurance activities and ... * Demonstrates an understanding of current events that have in?uenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well… more
- Veterans Affairs, Veterans Health Administration (Dayton, OH)
- …from FDA and accrediting agencies. Develops, implements, and evaluates quality control (QC) and proficiency testing programs; monitors corrective actions for ... results, including off-hour and weekend work, ensuring compliance with CAP, CLIA, AABB, FDA , and Joint Commission standards. Directs and advises Blood Bank staff in… more