Cipla | Group Leader - Medical Devices - Regulatory Affairs

Responsibilities:

• Support R&D teams during Design Control activities of device constituent part in combination products through preparing of design input (creation of URS considering all product-specific regulatory requirements), design output documents, risk management, design verification (ensure all aspects of verification requirements as per regulatory expectation is covered for combination product/ devices) and validation plans & reports (Ensure design, documentation and regulatory filing requirements are fully compliant to all Threshold Analysis, Human Factors and usability engineering related guidance and standards)
• Support R&D teams in compilation and perform preparing of technical file/design history file/design dossier documents against regulatory requirements
• Support R&D teams in validating necessary documentation requirements during design transfer to device manufacturing facility, as per regulatory requirements
• Work with R&D and cross-functional teams to evaluate proposed device design changes for regulatory impact and to suggest developing necessary documentation
• Intimate/escalate any delays in device design control activities to manager on monthly basis
• Support Respi, CDT team in preparing dossier sections for combination products involving device constituent part and devices by providing relevant inputs as per requirements/procedures/guidelines and preparinging relevant sections within the specified timelines
• Support Regional Regulatory teams in applying and obtaining approval for registration for combination products involving device constituent part and devices

• Maintenance of global registration/approval database and archive licenses for stand-alone devices worldwide
• Keep abreast on current device and combination product related global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
• Upkeep of appropriate regulatory documentation related to devices and combination products involving device constituent part are created and properly maintained (e.g. Project Design & Development Plan, Risk Management, design input, design output, design verification, design validation, design transfer).
• Provide device regulatory support to currently marketed devices.
• Maintenance of Device Regulatory files to support compliance with regulatory requirements.

Relevant experience:

10 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.