Cipla | Group Lead - Medical Devices Regulatory Affairs

JD

Ensure support to R&D teams as Device Regulatory partner for all Combination Products and Devices to guide on US-FDA / EU-MDR regulatory requirements pertaining to device constituent part in combination products & device regulatory requirements for device approval in target countries. Collaborate within Regulatory Affairs team and work with Respi, CDT & Regional regulatory teams on compiling dossier sections pertaining to combination products and devices by reviewing relevant sections as per requirements/procedures/guidelines within the specified timelines.

Accountability Cluster

Support R&D teams (Device team and F&D teams) on regulatory requirements for device constituent part in combination products and device regulatory aspects

Support Respi, CDT & Regional Regulatory teams

Support development, filing and commercialization of Standalone medical devices

Act as Point of Contact for Device Regulatory aspects within the Regulatory team

Support cross-functional teams

Support CQA & Manufacturing teams during inspection of combination products or devices

Monitor external device development partners / device manufacturers of device constituent part of combination products or devices to ensure regulatory compliance

Relevant experience:

8-9 years of experience in the Filing Drug Device Combination product / standalone medical devices. Have independently handled registration and post registration activities including life cycle management and regulatory compliance activities.