- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Develop, implement, and maintain design control procedures, ensuring compliance with FDA QSR, ISO 13485, MDR, and other relevant regulatory requirements. + Act ... plans. + Participate in internal and external audits, including FDA inspections, Notified Body audits, and customer audits. +...practical application of medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, ISO… more
- Access Dubuque (Dubuque, IA)
- …from regulatory agencies. Other duties include: + Assures regulatory compliance to ISO 13485, FDA 21 CFR 820, and Medical Device Single Audit Program. Lead the audit ... post market surveillance and reporting requirements. + Guides inspectors during FDA inspections, Notified Body audits, customer audits, and other such audits;… more
- University of Pennsylvania (Philadelphia, PA)
- …prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing ... pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA , as well as organize and maintain all regulatory affairs documentation/files… more
- Adecco US, Inc. (Cayey, PR)
- …Asegurara el cumplimiento de estandares de calidad, guias de la FDA y buenas practicas de documentacion. **Responsabilidades principales** Seleccionar y analizar ... areas de trabajo limpias (6S) y cumplir con normas de seguridad, FDA y politicas ambientales. Participar en actividades de mejora continua (SBU). **Requisitos**… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …with departmental procedures. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... Related warehouse and inventory control experience in a pharmaceutical, GMP, or FDA regulated environment is preferred. + Requires a basic understanding of material… more
- Adecco US, Inc. (Cayey, PR)
- …con los objetivos de la empresa, procedimientos internos y estandares regulatorios ( FDA , ISO y Calidad Central Corporativa). Este rol garantiza la implementacion ... experiencia** en un ambiente de manufactura regulado por la FDA , con experiencia directa en protocolos de auditorias ...FDA , con experiencia directa en protocolos de auditorias FDA /GMP. + Solidos conocimientos en protocolos CAPA, ISO 1401,… more
- Ultralife Corporation (Newark, NY)
- …personnel to maintain and update Ultralife's quality management system to ISO, FDA QSR, FAA and other applicable requirements. + Coordinate 3rd-party internal audits ... system requirements, in particular ISO 9001 and ISO 13485; familiarity with FDA QSR preferred + Solid technical understanding of manufacturing engineering principles… more
- Cardinal Health (Columbus, OH)
- …prescription drugs as they are distributed in the United States. Aimed to enhance FDA 's ability to help protect consumers from exposure to drugs that may be ... drug supply chain to protect US consumers. Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party… more
- Lilly (Indianapolis, IN)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... + Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for… more
- Kelly Services (Lodi, CA)
- …11 platform, ensuring manufacturing stays state-of-the-art and compliant with FDA regulations.** **Key Responsibilities:** + Upgrade PC-based control systems to ... by executing Installation and Operational Qualification (IQ/OQ) protocols consistent with FDA regulations. + Work with applications such as Rockwell FactoryTalk View… more