Senior Regulatory Affairs Specialist

Role Overview

• Manage India regulatory activities for medical devices, including registrations, renewals, variations, labelling compliance and lifecycle management
• Compile and submit registration documents, liaise with regulatory authorities and consultants to ensure timely approvals
• Assess regulatory impact of post-approval changes including design changes, labeling changes, warehouse changes, supplier or manufacturing site changes
• Support post‑market regulatory activities, including Adverse Event reporting, Field Safety Corrective Action (FSCA)/Recall
• Monitor and communicate regulatory intelligence and assess impact; maintain regulatory documentation and databases, utilize Regulatory Information Management Systems (Veeva RIM)
• Support assigned regulatory activities across ASEAN markets to enable compliance and business objectives

Requirements

• Bachelor’s Degree/ Diploma in Life Sciences, Engineering or other related discipline
• Minimum 3 years of RA experience within medical device industry
• Experience with India CDSCO submissions for medical devices
• Good knowledge of India MDR & ASEAN regulatory frameworks
• Working knowledge of ISO 13485 requirements
• Strong written and communication skills
• Ability for minimal travel required at 10% or less within India and abroad

Benefits

• Health care program
• Paid time off
• Flexible working arrangements
• Professional development opportunities