Quality Specialist
/211;ISO 13485, ISO 14971, CMDR, MDD and JPAL is preferred. Solid grasp of computer systems used in a manufacturing...
/211;ISO 13485, ISO 14971, CMDR, MDD and JPAL is preferred. Solid grasp of computer systems used in a manufacturing...
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...
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...
and equipment Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards Participate in FDA...
requirements in generating periodic PMS related reports Participate in projects to align with BD Quality, MDD/MDR strategies...
regulations and standards. Working knowledge of QSR’s, ISO 13485, MDD, MDR, CMDR, and FDA requirements and standards. A working...
to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions... System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD...