ZEISS in India
ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics.
ZEISS India has 3 production facilities, R&D; center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace.
Further information at ZEISS India.
Primary duties and responsibilities
Regulatory Strategy & Execution (APAC with Global Alignment)
Execute regulatory strategies for APAC markets aligned with global regulatory strategy
Define regulatory pathways including classification, submission routes, and documentation requirements.
Ensure regional submissions comply with both local authority’s expectations and global standards.
Tailor regulatory strategies to APAC market needs by incorporating local reimbursement, market access,



and competitive intelligence considerations into regulatory planning for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements.
End-to-End Submission Ownership
Support and guide SSC RA teams to prepare, compile, and submit regulatory dossiers across APAC markets.
Support and guide SSC RA teams to manage authority interactions including deficiency responses, clarifications, and approvals.
Ensure consistency of dossiers with EU Technical Documentation / US FDA submissions where applicable and defined intended purpose of use.
Lead or oversee (electronic) submissions via country‑specific digital portals and gateways (e.g. NMPA, PMDA, TGA, HSA, CDSCO, MFDS systems as applicable), ensuring correct use of local e‑submission formats, templates, and structured data requirements.
Lifecycle & Change ManagementAssess regulatory impact of product and process changes considering:
APAC country requirements
EU MDR change control expectations
US FDA design ch

📌 Regulatory Affairs Manager (Bengaluru)
🏢 ZEISS Group
📍 Bengaluru