Regulatory Affairs Expert

Overview

Regulatory Affairs Expert responsible for independently managing Product Regulatory Affairs activities to ensure compliance with applicable regulations and standards.

What you'll do

• Manage global regulatory product documentation including technical files, registration dossiers, IFUs, and labeling.
• Ensure compliance with global medical device regulatory and testing requirements during product design and development.
• Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities.
• Align global regulatory product availability with commercial strategy by managing registrations, renewals, and submissions.
• Drive regulatory assessments for product and process changes, including software updates, patches, and cloud-infrastructure changes.
• Lead regulatory aspects of product and process changes, including regulatory documentation.

What you'll need

• Minimum 8–10 years’ experience in Regulatory Affairs or Quality Assurance in medical devices or medicinal products.
• Master’s degree in Technical, Engineering, or Scientific fields.
• Knowledge of development and manufacturing processes.
• Familiarity with ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, and IEC 81001-5-1.
• Strong knowledge of global medical device regulations including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, and NMPA.
• Experience with cybersecurity and data protection (GDPR) and cloud compliance frameworks for medical devices.
• Fluent English in written and spoken communication.

Details

• Location: Bangalore, Karnataka, India.