- University of Colorado (Aurora, CO)
- …Maintain detailed records of studies including Patient Source Document Binder to ensure compliance with requirements of the Food and Drug Administration ( FDA ), ... Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration ( FDA ) audits and responses + Participate in subject recruitment efforts, including… more
- Catalent Pharma Solutions (Chelsea, MA)
- …needs.** **Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, ... assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control… more
- Envista Holdings Corporation (Madison, WI)
- …maintaining an emphasis on continuous improvement + Support Envista Business System and FDA /ISO compliance by adhering to all procedures and work instructions ... reviewing designs and deliverables from design partners. + Assures product quality by designing testing methods; testing prototypes; confirming manufacturing and… more
- Medtronic (Mounds View, MN)
- …will join a world-class team of systems, mechanical, electrical, software, and quality engineers within Medtronic's Surgical Operating Unit (OU). The Surgical OU ... for medical devices and embedded systems. It is not an IT security, compliance , or GRC-focused position. The ideal candidate will have deep experience working with… more
- Chiesi (Boston, MA)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... get content approved to support business needs + Ensures regulatory compliance while effectively managing business risks + Understands global promotional strategies… more
- Kedplasma (Norman, OK)
- …returning equipment to service. + Identifies potential, serious, or chronic problems affecting quality of compliance . + Maintains a clean, orderly, and efficient ... Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make… more
- Abbott (Chicago, IL)
- …Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement ... CI/CD workflows for ML models, including testing, rollout, rollback strategies, and compliance governance. + Ensure strict compliance with regulatory and privacy… more
- University of Utah (Salt Lake City, UT)
- …negotiating study contract budget and payment terms. 13. Maintain documents as required by FDA , ICH , GCP , and IRB regulatory guidelines. 14. Maintain contact with ... for trial completion. Review study related data to assure compliance with study protocol. This job description is not...communication skills also required. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of… more
- ARTIDIS (Houston, TX)
- …and optimize measurement protocols, and ensure the highest standards of data quality , reproducibility, and regulatory compliance . You will work closely with ... documentation, study reports, work instructions (WIs), and test plans in compliance with FDA regulations and ISO 13485 standards. + Provide on-site support and… more
- Kelly Services (Eagan, MN)
- …optimize formulations from concept to commercial scale. + Ensure compliance with FDA regulations, cGMP standards, and internal quality protocols. + Scale up ... care or OTC product formulation. + Strong knowledge of FDA regulations and cGMP compliance . + Demonstrated...Strong knowledge of FDA regulations and cGMP compliance . + Demonstrated leadership and cross-functional project management. +… more