regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Ability to analyze and interpret...
regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Ability to analyze and interpret...
14971, ISO 13485, and MDD 93/42/EEC Communication proficiency;verbal and written. Problem Solving and Critical Thinking...
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...
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...
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...