- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities:** ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- Charles River Laboratories (Wilmington, MA)
- …service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues. ... proudly supported the development of ~85% of the drugs approved by the FDA in 2019. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity… more
- Stanford Health Care (Palo Alto, CA)
- …Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label ... use) require a patient-specific order in advance from the supervising physician.11). After appropriate training, assists the supervising physician in the operating room (OR).Acts as first or second assistant under the supervision of an approved supervising… more
- UNC Health Care (Hendersonville, NC)
- …clinical care for patients enrolled in a clinical trial while adhering to all FDA , OHRP and GCP guidelines and regulations. This position has a central role in ... ongoing consent process is performed and documented in compliance with FDA , International Conference on Harmonization Good Clinical Practice (GCP), institutional,… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance** + Ensure adherence to IEC 62304 ... Imaging, Surgical Navigation or Medical Image Processing is a plus + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance. + Strong communication and… more
- Zimmer Biomet (Warsaw, IN)
- …Zimmer. **What Makes You Stand Out** + Must have experience with the following: + FDA regulated industry experience with extensive knowledge of FDA 21 CFR Part ... 820, Part 803 and Part 806, ISO13485, and ISO17971; + Microsoft Office Suite, Blueprint reading and geometric dimensioning and tolerancing; + QSR/ISO regulations, design assurance, FMEA, and product testing methods; + Six Sigma project experience; + Training… more
- Zimmer Biomet (Englewood, CO)
- …timelines * Assisting project teams on compliance with purchasing requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards * ... team-oriented operation. * Accurately represents quality processes to 3rd party auditors ( FDA , ISO 13485, MDSAP, etc.) * Other duties as assigned **Your Background**… more
- Winland Foods (St. Louis, MO)
- …reflected in SQF/BRC as well as the regulations of governing agencies such as OSHA, FDA and EPA and assuring employees are trained in these standards and comply with ... of food safety and food quality standards and regulations preferred. Experience with FDA and SQF/BRC a plus. + Experience in Continuous Improvement Programs a plus… more
- Lilly (Indianapolis, IN)
- …and Canada regulatory authorities. + Build, maintain, and leverage relationships with FDA , Health Canada, team members, and partner companies as appropriate. + ... Execute high quality communications with FDA , Health Canada, and internal customers to articulate and ensure understanding of the regulatory strategy and complex… more