and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab Ability to work...
in review and compilation of the submission files to obtain market approvals in the USA (510(k), Canada, Europe (MDD/MDR...
for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues..., previous MDD, etc.). Perform other duties as assigned. Minimum Requirements : Minimum of a Bachelor's degree...
such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S...
: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD...
. Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable...
and equipment Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards Participate in FDA...
requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ,OQ...
with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA...
requirements in generating periodic PMS related reports Participate in projects to align with BD Quality, MDD/MDR strategies...