Regulatory Affairs Professional

About the role

Seeking an experienced Regulatory Affairs Professional to lead / manage regulatory compliance activities for our Medical Device and In-Vitro Diagnostic (IVD) manufacturing operations. The ideal candidate will have strong expertise in Indian & international medical device regulations, regulatory submissions, quality management systems & liaison with government authorities & certification bodies.

What you'll do

• Regulatory Affairs & Licensing
• Prepare, review & submit applications for: Manufacturing licenses for IVD assays
• Act as the primary point of contact with CDSCO, State FDA & other regulatory authorities
• Respond to regulatory queries, deficiency letters, inspections & audits
• Coordinate and support regulatory filings and approvals for: CE Marking/ US FDA submissions/ MDSAP requirements/ WHO-related applications and registrations

What you need

• 8–12 yrs of experience
• Regulatory affairs
• Documentation
• Safety management
• ISO 9001
• Any graduate