such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia, Borderline Personality Disorder (BPD) and Substance...
, ISO 14971, IEC 60601-1, IEC 60601-2-18, FDA and MDD. Experience developing embedded systems with optics for medical...
International Standard, CMDCAS, FDA, and MDD/MDR regulations. We operate the Quality System as an overall management system...
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...