Proficient in preparing & submitting regulatory fillings for product approvals, conducting clinical evaluations, managing risk assessments, ensuring post market compliance. Experienced in EU MDR 2017/745, US FDA, Indian MDR 2017 & ISO 13485 Standards°Candidate from Medical Device company will be preferred. Deeply knowledge of EU MDR 2017/745, CE Marking, US FDA, Indian MDR 2017, ISO 14971 and Risk Management is mandatory for this position.°