- Cook Medical (Bloomington, IN)
- …as necessary.- May interface with internal or 3rd party audits. (eg FDA , Notified Body, etc.)- Drive continuous improvement efforts through facilitating, leading, ... and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. Must work and… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the operations department to setup… more
- L3Harris (Mason, OH)
- …well as L3Harris policies and procedures. + Monitor and support compliance with FDA regulations for imports; Temporary Import under Bond shipments; ATA Carnets and ... Control (OFAC), US Customs regulations and other participating government agencies (ie FDA , FCC, ATF). + Experience working with freight forwarders and customs… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices using Good… more
- Beth Israel Lahey Health (Burlington, MA)
- …aspects of clinical trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and educator for clinical ... computer systems, including web based applications; Working knowledge of medical terminology, FDA , OHRP and GCP regulations and medical practice protocols; In the… more
- Dentsply Sirona (Charlotte, NC)
- …erforderlich sind und den Anforderungen von ISO 14155, EU MDR und FDA entsprechen. + Vorbereitung und Einreichung von Dokumentationen zu klinischen Studien bei ... der Durchfuhrung klinischer Studien am Menschen (z. B. ISO 14155, EU MDR, FDA , DSGVO, Deklaration von Helsinki, Gute Klinische Praxis (GCP) und EU-KI-Gesetz). +… more
- UTMB Health (Galveston, TX)
- …or marketing permits for products regulated by the Food and Drug Administration ( FDA ), including products submitted via the Animal Rule pathway. The office also ... manages a collaborative educational grant with the FDA to promote data integrity for the development of medical countermeasures for high consequence pathogens. **Job… more
- Takeda Pharmaceuticals (Boston, MA)
- …stakeholders within the organization and externally with platform vendors, RWE innovators, FDA etc. + Act as a knowledge developer and repository around ... observational studies, FDA policies, publications etc related to RWE. + Be at the forefront of advanced technologies like Gen-AI/agentic AI and their applications of… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... or a ZOLL development plan required. + Strong understanding of ISO 13485 and FDA GMPs preferred. + Experience with database queries and reporting in SQL or Microsoft… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …control policy research and systems science. The position is part of the UNC NIH / FDA -funded Tobacco Center of Regulatory Science ( TCORS ). The broad theme of the ... UNC TCORS is building the science for effective FDA public health decision-making about tobacco products. The specific project the postdoc will work on uses… more