under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
, 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...
that are compliant and conform to 21 CFR 820, MDD/MDR, and ISO 13485:2016. Responsibilities Under direction, Engineering Interns...
management System, ISO 14971:2019 Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive...
. This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device requirements... Other duties may be assigned, in addition to those identified below Ensures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR...
psychology and emerging medications to treat disorders such as MDD, GAD and PTSD empathetic and approachable...
requirements (FDA, ISO-13485, MDD 93/42/EEC, Health Canada regulations, etc.) preferred. Why Apply to Drive DeVilbiss...
processes. Prepare plans and documentation required to participate in the Material Development Decision (MDD), the pre-/post...
. Prepare plans and documentation required to participate in the Material Development Decision (MDD), the pre-/post-Acquisition...
devices (e.g., ISO, MDD/MDR) High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel...
), Multi-Department Direction’s (MDD), and Department Instructions (DI’s). Qualifications: Education/Experience: High...
), Multi-Department Direction’s (MDD), and Department Instructions (DI’s). Qualifications Education/Experience: High...
of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in...
, FDA, MDD and regulations applicable to the design and development of medical device/science/technology. Encounters...
, validation, and manufacturing. Exceptional verbal and written communication skills. Familiarity with ISO 13485, MDD, and FDA...
(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments...
Surveillance• Knowledge on Medical Device Regulatory Standards, MDD and MDR• Knowledge on NC, CAPA, Audit processes• Medical...
regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge on NC, CAPA, Audit processes Knowledge in...