, specifically High Frequency surgical equipment. He/she serves as a key resource for ISO, EN, MDD, MDR, and QSR requirements... analysis. Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD / MDR, and NMPA...
of experience as a Clinical Research Associate 4-year university degree or RN/BSN in Nursing Experience in CNS, preferably MDD...
knowledge of Medical Device regulations (21CFR820, European MDD, Canadian MDR, etc.). Understanding and application...
to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as ISO 13485/MDD...
language. Solid understanding of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations...
Device Regulation (CMDR) and EU Medical Device Directive (EU MDD 93/42 EEC), Quality Business System and Key Corporate...
Regulatory Affairs Specialist will focus on assisting with maintaining product compliance with FDA/MDSAP, ISO, and MDD/MDR... as well as develop procedures and strategies for maintaining compliance. Maintenance of FDA/MDSAP, ISO, and MDD/MDR...
regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country...
reports Familiarity and the ability to comply with Regulation (21 CFR 820, EU – MDD & MDR) cGMP (current Good Manufacturing...
Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws. Outstanding problem-solving...