Purpose of this position / Position summary:
The Regulatory Affairs Manager– APAC is an individual contributor responsible for independently managing regulatory submissions, ap-provals, and lifecycle compliance across APAC markets. The role also requires strong global regulatory awareness, including EU MDR, US FDA, and MDSAP frameworks, ensuring alignment of regional activities with global compliance expectations. The role covers a broad portfolio of medical devices (including but not limited to ophthalmic devices, intraocular lenses, contact lenses, surgical accessories), drug products such as ophthalmic eye drops, as well as cosmetics and dietary supplements where applicable in the Asia Pacific region. The Regulatory Affairs Lead – APAC is responsible for ensuring that market access strategies, submissions, and lifecycle activities reflect coun-try specific market needs, regulatory expectations, and competitive dynamics in key APAC markets (e.g. China, Japan, South Korea, Aus-tralia, Current Zealand, India, ASEAN countries).
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 com-petitive 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 Documentat

📌 Regulatory Affairs Manager (Bengaluru)
🏢 Zeiss India
📍 Bengaluru