Harjeet Kaur

Regulatory Affairs Specialist @Tata Consultancy Services

Delhi, IN

Prepare complex regulatory submissions and/or presentations to regulatory bodies (i.e. FDA, BSI, Notified Bodies, etc.) and for any related communications Preparing the MDR application and technical file for disposable and active devices to EU Notified Body (BSI-Netherland). Prepare NC’s responses for EU MDR (BSI). Performed detailed gap analysis on technical documents of medical device to identify gaps in bio-compatibility, Packaging, Stability Assessments, Input Output Matrix, Risk Management etc. with respect to Annexure - I GSPRC of MDR. Working in close collaboration and partnering with other departments like R&D, manufacturing, quality, etc. Reviewing proposed modifications to intended use, design, labeling, materials, and manufacturing processes to assess impacts on existing regulatory approvals/ clearances. Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations. Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. Provides regulatory information and guidance for proposed product claims/labelling. Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.

Vmps

Pharmacy

BSAIP,MDU

Bachelor’s Degree