Hiring: Regulatory Affairs Associate – Medical Devices | APAC
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 6060