clinical studies, and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485...
Position Overview: In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist...
regulations and standards Responsibilities Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical...
of regulatory expectations and industry practices including industry standards QSR, ISO13485, and MDD. Other Skills and Abilities...
under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
environment. Ensure projects are executed in compliance with regulatory requirements (GMP, ISO, MDD) & JJMT policy & procedure...
management System, ISO 14971:2019 Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive...
, MDD 93/42/EEC and FDA QSR. Duties and Responsibilities: Review and develop process instructions for our products... operations in accordance with ISO 13485, MDD 93/42/EEC and FDA QSR. Duties and Responsibilities: Review and develop process...
requirements (GMP, ISO, MDD) & JJMT policy & procedure requirements. Excellent ability to convey complex technical information...
investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union...