Self motivated, positive and result driven Regulatory professional with 4+ years experience in regulatory affairs for medical devices and quality control in the pharmaceutical industry.
Good understanding of ISO 13485 requirements, risk management, 21 CFR 820, 21 CFR 807, bio compatibility requirements, ICH guidelines, STED format for medical device submission, EU Medical Device directives and Quality System regulations.
Faced audits by USFDA, ANVISA, GDPMDS (HSA) and managed complete product life cycle for wide range of products.
Hands on experience in ASEAN CSDT for medical device submissions.