- Bristol Myers Squibb (Summit, NJ)
- …years of leadership/managerial experience required. + Experience in participating and supporting regulatory audits preferred: FDA , MHRA, PMDA, etc. + Experience ... Sterility Assurance is responsible to act as the SME during regulatory inspections. **Duties/Responsibilities** + To support final product testing and release,… more
- System One (Walnut Creek, CA)
- …ensures that all study activities are performed in compliance with ICH-GCP, FDA , and institutional standards, prioritizing participant safety, data integrity, and ... regulatory compliance. The PI serves as the main point...Sub-Investigator in clinical research. + Strong understanding of ICH-GCP, FDA regulations, and clinical research ethics. + Proven leadership… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** Manages all Quality Control (QC) laboratory instrumentation and metrology activities to support GMP manufacturing, testing, and release of ... materials, intermediates, and finished products under FDA /EU regulations, applicable international regulations, and BeOne processes and procedures. Ensures GMP… more
- Abbott (Liberty, SC)
- …Material Review system. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other … more
- Mentor Technical Group (Durham, NC)
- …principles, cleanroom classifications, and sterile technique. + Familiarity with GMP, FDA , and regulatory requirements for sterile manufacturing. + Knowledge ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Stryker (Mahwah, NJ)
- …in CAD software (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: Medical and ... & Validation: + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards. + Establish robust process controls and capability… more
- Beth Israel Lahey Health (Burlington, MA)
- …general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research ... medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. +… more
- Globus Medical, Inc. (Eagleville, PA)
- … requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other … more
- Colgate-Palmolive (Piscataway, NJ)
- …Knowledge of Regulatory environment across the globe + Knowledge of ICH/ FDA guidelines for stability and testing of new drug products **Compensation and ... + Create and maintain all required R&D documentation to ensure flawless, high- quality commercialization. + Maintain all required documentation under **GMP/GLP** per … more
- Cedars-Sinai (Los Angeles, CA)
- … FDA , OHRP, HIPAA and other agency guidelines. + Maintains high quality , up-to-date regulatory files (CITI and other training documents, financial ... integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for...disclosures, FDA forms, CVs, medical licenses, etc.) for research studies.… more