Regulatory Affairs Manager - Mat Leave / FTC
of ISO 13485, 14971, 15223, UKMDR 2002, MDD 93/42/EEC AND MDR 2017/45. Methodical, with analytical and problem-solving...
of ISO 13485, 14971, 15223, UKMDR 2002, MDD 93/42/EEC AND MDR 2017/45. Methodical, with analytical and problem-solving...
and regulations governing such as MDD/MDR, UK CA, EU CE, US CFR21 Key electro-mechanical ISO standards (eg. BS EN ISO 60601-1:12...
depth knowledge of ISO13485:2016, MDD 93/42/EEC Have comprehensive knowledge of WHTM documents ensuring that departmental... of ISO13485:2016, MDD 93/42/EEC Have comprehensive knowledge of WHTM documents ensuring that departmental production operates...
Knowledge of ISO 13485, MDD, MDR Excellent attention to detail Within a commutable distance to West Yorkshire as this role...
for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations...
series). Extensive experience in QA/QS within the medical device or pharmaceutical industry. Knowledge of ISO 13485, MDD 93...
. To maintain all validation/calibration certification required for MDD registration. To maintain spare parts and tools store...
regulatory files such as STED and EU MDD/MDR Technical Files. Participate in cross-functional product development teams as the... support transition of products from MDD tech files to MDR technical documentation and any other business critical projects...
with manufacturing / production in quality control Knowledge in processes for transition from EU MDD to EU MDR...
certification required for MDD registration. Maintain spare parts and tools store and advise the Regional Engineering Manager...