Regulatory Affairs Specialist

Philips — Gurgaon

Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist – ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added regulatory affairs service and deliverables for existing products, new product introductions and product changes across the ISC. supporting SAP Regulatory controls to ensure products are safe, effective, and meeting the target market Regulatory requirements. You are responsible for • Supporting RA Team for the Indian Sub Continent to ensure on time registrations, monitoring and assessment of changes in regulations, review of product changes and regulatory assessment, ensure compliance to applicable regulations. • Responsible for planning, supporting RA Submissions, approvals, renewals and compliance to applicable act and rules under following ministries- 1. Atomic Energy Regulatory Board 2. Ministry of Communication and IT (DOT)- Wireless Approvals\Ministry of Communication and IT (DOT)- Wireless Approvals 3.Ministry of Health (CDSCO) – D&C Act and Medical Device Rules 4.PC&PNDT Act and Rules 5. Bureau of Indian Standards- ISI Marking and Accessories required to comply with METY registration order (Registration marking registration Scheme) 6. Ministry of Environment and Forest- Preowned Medical Equipment 7.Ministry of Electronics And IT- (MIETY) 8. Ministry of Chemicals and Fertilizers- NPPA Compliance as per Drugs Price Control Order (Notified Medical Devices are regulated as Non-Scheduled formulation) 9. NMRA (Sri Lanka) -National Medicine Regulatory Authority 10. DGDA (Bangladesh) - Directorate General Drug Administration • Support RA manager for Operations / supply chain in addressing regulatory queries from customs • Support to Govt Sales team in addressing regulatory queries/ clarifications • Support to customers query with regards to AERB compliance, customs with regards to CDSCO, AE

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