- Bristol Myers Squibb (Indianapolis, IN)
- … regulatory filing. . Review and author CMC sections for IND/NDA for FDA submissions, and support regulatory filing in other jurisdictions, eg EMA, Health ... Canada, etc. . Collaborate cross-functionally with Regulatory , Quality , Supply Chain, Clinical, and R&D teams to ensure alignment with corporate goals . Up to… more
- ThermoFisher Scientific (South San Francisco, CA)
- …support of the business units. **Discover Impactful Work:** Your work will impact the quality of the FDA submissions and help secure the necessary approvals for ... Description** **Location/Division Specific Information** This position is part of the Regulatory and Clinical Affairs organization which ensures that the internal… more
- United Therapeutics (Morrisville, NC)
- …approve SOPs, test methods, and product specifications to ensure alignment with regulatory requirements, internal quality standards, and industry best practices ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Owens & Minor (Woodland, CA)
- …skills in diagnostics, repairs, and safety procedures.) . Ensures all Human Resources, Regulatory , Joint Commission, FDA , and Legal training is completed on time ... THE COMPANY Apria Healthcare's mission is to improve the quality of life for our patients at home. We.... Knowledge of safety and compliance regulations (OSHA, DOT, FDA , and CHAD). . Must meet eligibility requirements for… more
- FST Technical Services (Holly Springs, NC)
- …project drawings, specifications, codes, and regulatory requirements (eg, ASME, cGMP, FDA , ISO). Quality Oversight + Oversee and verify inspection results, ... with our team in Holly Springs, NC! Job Title: Project Manager - Industrial Quality Inspection Position Overview The Project Manager will oversee all aspects of … more
- Hologic (Newark, DE)
- …a meaningful impact on healthcare innovation. **Knowledge:** + Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device ... thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make… more
- US Foods (Fairburn, GA)
- …teams, budgets, and vendor contracts. + Strong understanding of OSHA, EPA, USDA, FDA , GMP, and other regulatory compliance requirements. + Proficiency with CMMS ... food distribution environment, this role ensures cold chain integrity, regulatory compliance, and operational uptime through proactive preventive maintenance and… more
- US Foods (Grand Island, NE)
- …teams, budgets, and vendor contracts. + Strong understanding of OSHA, EPA, USDA, FDA , GMP, and other regulatory compliance requirements. + Proficiency with CMMS ... ensures proactive preventative maintenance and rapid issue resolution to ensure regulatory compliance and operational upkeep of all company owned equipment,… more
- Danaher Corporation (San Diego, CA)
- …operation, and support of our products. You will collaborate closely with R&D, Quality , Regulatory , and Service & Support stakeholders to translate complex ... ensuring high- quality deliverables support the product roadmap. + Ensure regulatory compliance by creating and maintaining all labeling, including user guides,… more
- Caris Life Sciences (Phoenix, AZ)
- …and maintenance program. **Job Responsibilities** + Maintain compliance to all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA , IVDD, etc.) with ... also responsible for assisting in company-wide compliance to all applicable regulatory requirements and assisting with the day-to-day operations of the laboratory's… more