Regulatory Affairs Executive / Sr Executive -IVD

• Prepare, review, and submit regulatory dossiers for IVDs & Medical Device products to CDSCO zonal office and Head Quarters and State DCA, Telangana.
• Manage applications related to Test License, manufacturing licenses, product permissions, endorsements, amendments, and renewals under the Medical Devices Rules (MDR), 2017.
• Prepare responses to regulatory queries and deficiency letters issued by regulatory authorities.
• Handle regulatory submissions and Hands-on experience through the CDSCO and State DCA online portals, and manage all regulatory correspondence to ensure timely submission, effective follow-up, and receipt of required approvals.
• Coordinate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Production, to collect, compile, prepare, and maintain technical documentation required for regulatory submissions in compliance with applicable regulatory requirements and evaluate regulatory changes and communicate their impact to cross-functional teams.
• Responsible for preparing and reviewing the Device Master Files of various IVDs & MD.
• Review product labels, Instructions for Use (IFU), package inserts, and promotional materials for regulatory compliance.
• Support new product registrations and lifecycle management activities.
• Experience with Class A, B, C, and D IVD product registrations.
• Knowledge of ISO 13485, Quality Management Systems, and Good Documentation Practices (GDP).
• Experience in post-market regulatory activities and license maintenance.
• Ability to interact confidently with regulatory authorities and cross-functional stakeholders
• Maintain regulatory records, licenses, approvals, and submission trackers.
• Assist during regulatory inspections and audits by CDSCO, DCA, and other competent authorities.
• Support change control assessments from a regulatory perspective.
• Ensure compliance with applicable Indian regulatory guidelines and standards for IVDs and medical devices.
• Monitor renewal timelines and ensure timely regulatory compliance.

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