Senior Clinical Project Manager
through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD...
through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD...
properties. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD...
and ISO 13485, MDD requirements. Audit experience a plus. BS degree. Excellent communication, interpersonal...
properties. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD...
industries) Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/EU MDR. Ability to author...
, MDD, MDR Understanding of medical device regulations Experience in auditing medical device manufacturing facilities...
and registrations (e.g., ISO, FDA, IVDD/IVDR, MDD/MDR), as well as product safety and regulatory compliance. Overseeing the regulatory...
and maintain the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP...
, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA...
Requirement Document BRD Functional Requirement Document FRD Minor Development Document MDD Jira Epics etc. · Facilitate project...