Regulatory Affairs Professional
VadodaraFull-time8–12 yrsPosted over a month ago
Leadership pharma role at Siemens Healthineers in Vadodara. Needs 8–12 years and a degree.
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
- Regulatory affairs
- Documentation
- Safety management
- ISO 9001