Regulatory Affairs Associate
Johnson & Johnson
Total years of experience :4 years, 8 Months
• Portfolio Handled: Orthopaedics, Trauma, Biologicals, Neurovascular & General Surgery
• Expertise in Online Medical device application submission
• Expertise in Medical device import license application submission to Health Authority of India (HA), also considering HA expectations and shaping the submission to address any gaps or concerns of the HA to achieve successful on-time approvals
• Change assessment/notification and its timely submission to CDSCO (Central Drugs Standard Control Organization), India
• Interfacing with cross-functional teams such as Sales, Marketing, Logistic team and supply Chain to devise internal strategies for regulatory submissions
• Created and submitted other Regulatory submissions such as query responses, corrections filings, adverse/serious adverse event reporting and miscellaneous/change notifications regarding post registration changes to maintain regulatory life cycle of product for India in accordance with applicable regulations and guidelines
• Working as per ISO 13485:2016 and Medical Device Regulations 2017
1) Performed Quality control testing of various pharmaceutical products (NABL accredited) available through indigenous & international manufacturers through DCGI by various biological and chemical testing.
2) Also looked after Quality Management System by the updating of all documentation as per ISO 17025:2005.
3) Active participation in NABL Audits, CDL Audits & Internal Audit.
1) Coordinated with clients (hospitals, laboratories etc.) looking for clean room facilities and understanding their demands according to International Standards to successfully deliver world class products to our customers.
2) Active monitoring of ISO 9001:2008 standards.
● Silver medalist ● Dissertation at M/s The Energy and Resources Institute (TERI) , Delhi
● Stood 1st. ● worked in student union. ● worked on a research project for 1 year. ● worked as class representative.