Senior Regulatory Affairs Specialist
selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents...
selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents...
Experience in medical software development (FDA or MDR/MDD/IVDR/IVDD regulated) Familiarity with common developer tool sets...
Affairs. Strong working knowledge of QSR, ISO 13485, MDD/MDR, ISO14971 (Risk Management), and Canadian Medical Device...
: Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR...
under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
with FDA, ISO 13485, MDD, EU MDR, CMDR and related quality system regulations Expansive knowledge of regulatory and quality...
of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR. Working knowledge and practical application of 21 CFR...
(e.g., FDA, ISO 13485, MDD/MDR) and industry best practices. Prepare and review documentation for regulatory submissions...
(e.g., FDA, ISO 13485, MDD/MDR) and industry best practices. Prepare and review documentation for regulatory submissions...
: Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR...