, MDR/MDD and other applicable global regulatory requirements and standards. Apply balance of risk, regulatory intent... of experience in design quality. Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO Quality standards...
Council Directive: 93/42/EEC Medical Devices Directive (MDD) EU Regulation: 2017/745 Medical Devices Regulation (MDR) MDSAP...
(including QSR, ISO, OSHA, IVDD, MDD) are met and the inspection schedule is satisfactorily attained. Analyzes work processes... - Strong leadership and organizational skills - Knowledge of current QSR, ISO, OSHA, IVDD, MDD regulations desirable...
and other health authorities (Highly preferred) Be knowledgeable of US cGMP regulations, industry best practices, EU MDD, and ISO...
with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs...: Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration...
, EU MDD/MDR and/or Canada including writing, compilation, submission, interaction with health authority(s), and continuing...
. Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM. Root cause analysis techniques...
resolution skills Specialized Knowledge: o Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system...
and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the.... Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223...