execution (technical, regulatory, business). Ensure department adherence to global regulatory requirements (FDA, EU MDR, ISO...
, audit, CAPA, supplier quality, 21 CFR, EU MDR. Knowledge of eQMS and Greenlight Guru. Understanding of FDA regulations..., Quality System Regulations 21 CFR Part 820, ISO :2016, EU MDR, ISO :2019. 8-10 years of experience in quality assurance...
and delivery. Demonstrated success overseeing global teams across US, China/APAC and EU and delivering complex, customer-facing...
(NA, LAM, EU, APAC, India) Experience working in TMF, CTMS, Sharepoint, Excels in written and verbal communications Self...
inspection, sampling, and testing of incoming raw materials prior to use in manufacturing, according to US and EU GMP...
in Arms Regulations or Export Administration Regulations, the EU Dual Use Regulation, and/or other export control regulations...
and existing products, product manuals, and product literature to ensure compliance with applicable US and EU regulations...
, reporting, and maintaining the US/CA/EU freight payment initiative. They will need to become the subject matter expert and work..., Advance Optimization, Ocean/Rail Implementations, ERS implementation for EU, Yard Management, etc.). Function as Freight...
regulations including EU Directives, ISO 14155. Compliance to Good Clinical Practice (GCP) and International Conference..., EU Directives and regulatory requirements Strong clinical study management skills including management of vendors...
compliance knowledge including 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU...