to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as ISO 13485/MDD...
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...
Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding...
, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601. Essential Job Functions... of applicable medical device regulations and standard such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42...
Part 820, EU MDD, EU MDR and other relevant regulations and standards. Participate in design reviews, test readiness...
. Extensive knowledge of various regulations/standards (E.g., 21 CFR 820, ISO13485, ISO14971, MDD/MDR). Preferred Skills...
in regulatory compliance guidelines for medical devices (e.g. ISO, MDD/MDR, CFR) Physical Job Requirements The above statements...
such as but not limited to, IEC 62304 and IEC 81001-5-1. EU Medical Device Directive (MDD) compliance. EU Medical Device Regulation (MDR...
. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs...