- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with raw materials or testing of raw materials that are included in FDA approved products/processes as well as with internal USP staff globally including: Program ... new monographs, modernization of existing monographs, and compendial requests to address FDA comments on proposed monographs to the USP-NF. + Develops specific plans… more
- Danaher Corporation (Chaska, MN)
- …engineering drawings, work orders, and other specifications while maintaining FDA requirements. Travel, Motor Vehicle Record & Physical/Environment Requirements: + ... previous experience in: + Experience in a regulated industry preferred (eg, FDA , ISO). + Proficiency with Microsoft applications, including Word, PowerPoint, and… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Holland, MI)
- …Essential Duties and Responsibilities + Assist in troubleshooting with USDA-FSIS and FDA regulatory issues and food safety or quality deviations. + Provide support ... on that data. + Must be able to read and interpret FSIS and FDA regulations and required certification codes. Certificates, Licenses and Registration + Should be… more
- Kerry (Vesper, WI)
- …Develop, review and align procedures with Kerry global standards and FDA /CFIA expectations. Internally audit against global and regional standards and site ... and regulatory audit compliance. Support the site for regulatory inspections ( FDA /CFIA), identify preserved (ie.organic, Kosher) and customer audits. + Quality… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …scheduling, vendor oversight) is a plus. + Familiarity with regulatory requirements ( FDA , EMA, OSHA, DEC) and quality systems (change control, investigations, CAPA) ... regulations, quality systems (change control, investigations, CAPA), and applicable standards ( FDA , EMA, OSHA, DEC). + Project Management Skills: ability to manage… more
- Hologic (Newark, DE)
- …Utilize phase/gate processes to execute programs in alignment with **ISO** and ** FDA regulations** , ensuring adherence to design control procedures and quality ... design cycles, and industry standards. + In-depth understanding of **ISO** and ** FDA regulations** , including design control procedures. + Expertise in risk… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Innovation & Continuous Improvement** + Identify emerging technologies and ... familiarity with robotics, sensors, and real-time control systems are preferred + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance. + Knowledge of… more
- J&J Family of Companies (Danvers, MA)
- …and standards (for example, IEC 60601-1 _IEC_ 60601-1 and applicable FDA guidance). + Experience with communication interfaces and embedded systems (UART, ... + Experience supporting regulatory submissions and preparing verification packages for FDA /Notified Body review. + Experience with complex fluidic systems and… 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
- Edwards Lifesciences (Chicago, IL)
- …+ Collaborate with Quality, Regulatory, and Compliance teams to meet industry standards ( FDA , IEC, NIST) + Design, document or improve key processes for the service ... + Secure Software Development Life Cycle (SSLDC) experience + Knowledge of FDA guidelines + Writing testable cybersecurity requirements + Risk management lifecycle… more