Experience: 2–3 Years | Location: Bengaluru
We are looking for a motivated and detail-oriented Regulatory Affairs Associate with 2–3 years of relevant experience in the medical device industry to join our team in Bengaluru.
The selected candidate will support regulatory activities for active and passive medical devices, including product registrations, technical documentation, regulatory submissions, compliance assessment, and coordination with regulatory authorities and internal product-development teams.
This role offers an chance to gain broader exposure to Indian and Asia-Pacific (APAC) medical device regulatory requirements and participate in the complete regulatory lifecycle of medical devices.
Key Responsibilities• Support preparation, compilation, review, and submission of regulatory dossiers for medical device registrations in India and APAC markets.
• Prepare and maintain documentation required for applications and submissions to CDSCO – Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017.
• Support activities related to:




• Medical device registration and licensing
• Import/manufacturing licence applications
• Product classification
• Device Master File / technical documentation
• Plant Master File documentation
• Regulatory renewals, amendments, and change notifications
• Responses to regulatory authority queries

• Assist in preparation and review of technical documentation for active and passive medical devices, including:
• Device description and intended use
• Product specifications
• Design and manufacturing information
• Essential Principles / General Safety and Performance Requirements
• Risk-management documentation
• Verification and validation documentation
• Clinical / performance evaluation documentation
• Labelling, IFU, packaging, and artwork review

• Support compliance activities associated with applicable international standards, including relevant requirements of:
• IEC 60601 series for electrical medic

📌 Regulatory Affairs Associate – Pharma And Medical Devices | APAC (Bengaluru)
🏢 Aria Innovations Private
📍 Bengaluru