Bhargavi Naik

Regulatory Affairs Specialist i @Argentum Medical Llc

Responsible for Medical Device submissions, license renewals, and global product registration activities. • Create and maintain product labeling throughout the product life cycle. • Create and maintain IFU throughout the product life cycle. • Create and maintain technical documentation regulatory files. • Identify regulatory submission requirements associated with new product introductions and changes to existing products (design control/change control). • Provide regulatory support for internal and external audits.