- Cardinal Health (Jacksonville, TX)
- …readiness efforts and facilitate regulatory, customer and corporate audits such as ( FDA and MDSAP) and customer technical visits and provide responses to findings ... product release to ensure patient safety. + Responsible for understanding ISO 13485, FDA QSR and other relevant standards and to apply them to continuous improvement… more
- Taiho Oncology (Princeton, NJ)
- …risks to TPC and also within TOI. + Prepare strategy and plans for FDA /EMA meetings in coordination with TPC and TOI members. Ensure rapid preparation and approval ... of and experience interacting and negotiating with regulatory agencies, particularly the FDA . + Experience in biologics and/or antibody drug conjugate a plus for… more
- Stryker (Mahwah, NJ)
- …processes, tooling, materials, and manufacturability considerations. + Ensure compliance with FDA , ISO 13485, and internal quality system requirements. + Maintain ... and tooling + Experience with process validation and regulatory compliance ( FDA , ISO 13485) Health benefits include: Medical and prescription drug insurance,… more
- Stryker (Mahwah, NJ)
- …Collaborate with Quality, Regulatory, and Advanced Technology to ensure compliance with FDA , ISO, and internal standards. + Identify and implement NPI best practices ... preferred) + Strong knowledge of DFM, process validation, and quality systems ( FDA , ISO 13485) **Preferred Qualifications:** + Experience with investment casting or… more
- Cordis (Miami Lakes, FL)
- …Regulatory & Systemic Expertise + Apply in-depth knowledge of ISO 13485, FDA QSR, and global regulatory expectations to guide supplier compliance. + Conduct ... manufacturing environments. **Preferred Qualifications** * Strong understanding of ISO 13485, FDA QSR, supplier audits, and global QMS standards. * Lean Six… more
- Sysco (Auburndale, FL)
- …industry standard safety policies and procedures - OSHA, NEC, NFPA, USDA, FDA , etc. + Perform inspections and complete preventive/predictive maintenance tasks on ... + Experience working in a food processing environment and familiar with USDA, FDA , and SQF policies and procedures. **Education** High School Diploma or GED… more
- CBRE (Reno, NV)
- …CBRE self inspection, client self inspections, or any external agency inspections like the FDA . Has the responsibility to lead audits as well as serve as the primary ... preferred. Previous supervisory experience a plus. **CERTIFICATES and/or LICENSES** FDA , ISO, or similar quality assurance audit related certification preferred.… more
- Chiesi (Boston, MA)
- …Regulatory and Compliance: + Ensure RWE studies meet regulatory standards (eg, FDA , EMA guidelines) for use in submissions and decision-making across global markets. ... would prefer for you to have + Experience working with regulatory agencies (eg, FDA , EMA) on RWE submissions. + Knowledge of health policy, payer dynamics, and HTA… more
- Stryker (Mahwah, NJ)
- …& Validation: + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards. + Establish robust process controls and capability ... (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: Medical and prescription drug… more
- WuXi AppTec (Middletown, DE)
- …construction management, schedule, safety management, process, commissioning & qualification per GMP/ FDA compliance. + Own the development and delivery of the ... and regulations while maintaining international standards + Good acknowledge of GMP/ FDA /ICH and implementation + Strong teamwork spirit + Strong communication and… more