, or related degree Minimum of 7 years of medical device engineering experience In depth familiarity with the FDA, ISO, MDD, EU...
knowledge of U.S. and international regulations and standards relevant to BSC, including 21 CFR 806 & 820, ISO 13485:2016, MDD...
device engineering experience In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality...
, or related degree Minimum of 7 years of medical device engineering experience In depth familiarity with the FDA, ISO, MDD, EU...
knowledge of U.S. and international regulations and standards relevant to BSC, including 21 CFR 806 & 820, ISO 13485:2016, MDD...
skills are required. Excellent written and oral communication skills essential. Working knowledge of FDA/ISO/MDD Quality...
Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws. Outstanding problem-solving...
organizational policies and procedures, regulations of the FDA, ISO 13485, the MDD, EU Medical Device Regulation (2017/745) Canadian...
while ensuring employee safety and product quality standards (FDA, ISO, MDD) are achieved. Maintenance Technician Qualifications...
electromechanical medical device) and ISO 22442 (Med Devices using animal tissues) and regulatory requirements (e.g., EU MDD and MDR...