- Lactalis American Group Inc. (Buffalo, NY)
- …all LUSA suppliers (Raws & Packs, CoMan) with the Group QFS standards & FDA standard; to ensure Business Continuity & Reputation. Lead the transformation of Q&FS ... suppliers on quality and food safety. . Ensure full compliance with FDA and Lactalis SQMP standards; cultivate win-win relationships with suppliers; and maintain… more
- HCA Healthcare (Las Vegas, NV)
- …in this role: + Provide guidance to facilities regarding JCAHO, CMS, NQSF, FDA standards, and State Board of Pharmacy Requirements. + Analyze and evaluate detailed ... medication management (ie State Board of Pharmacy, TJC, CMS, NQSF, IHI, and FDA standards). + Assist in the development, implementation and sustainment of charge… 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, ... managing budgets, schedules, and multi-disciplinary teams. + Familiarity with cGMP, FDA , and ASME B31.3 or equivalent standards. Certifications (Preferred) + PMP,… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …position plays a key role in leading teams through the development and FDA compliance issues involved with medical devices. The position requires the development of ... to lead projects involving resources in multiple locations + knowledge of FDA and ISO medical device development regulations + Project Management Professional (PMP)… more
- Markem-Imaje (Salem, NH)
- …actions or decisions conducted) comply to standards such as the ISO/TS/ASTM/ FDA /EU machine directive etc. + Champions compliance to applicable Global Regulations ... methods + Design of experiments + CGMP's, QSR's, ISO, TS (auto), AS (Areospace), FDA (food and Drug) and TQMS quality systems. + Risk Management and Hazard Analysis… 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
- Mount Sinai Health System (New York, NY)
- …reports, including milestone updates. + Assist in preparation of grant and FDA IDE submissions and renewals. Research Data Management + Oversee curation, ... and managing requests for data sharing. + Ensure compliance with IRB and FDA protocols, HIPAA regulations, and open data principles. + Coordinate integration of data… more
- Bausch + Lomb (Kirkwood, MO)
- …leadership, along with a thorough understanding of IEC 60601 standards, FDA and EU design control regulations, and risk management practices. **Responsibilities:** ... suppliers, and contract manufacturers when needed. + Support regulatory submissions (eg, FDA 510(k), PMA) and audits as the technical electronics subject matter… more
- Stryker (San Jose, CA)
- …software lifecycle by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and development activities for ... or similar, demonstrating strong technical skills + Experience with regulatory agencies ( FDA , MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601),… more
- Lilly (Indianapolis, IN)
- …reduce inspection errors. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection ... and equipment specific to parenteral products. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and experience with regulatory inspections. + Proven track… more