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Hiring companyCarl Zeiss

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Regulatory Affairs Manager

Bangalore, Karnataka, India Full-time On-site

About the role

Regulatory Affairs team at Carl Zeiss India drives compliance for ophthalmic devices, cosmetics and supplements across APAC. The manager leads strategy, end‑to‑end submissions, lifecycle and change management, and coordinates regional hubs and AI‑enabled tools. Bangalore, on-site, hybrid model with occasional travel to APAC sites.

What you’ll do

  • Develop and execute APAC regulatory strategies aligned with global standards
  • Own end‑to‑end dossier preparation, submission and authority interactions
  • Manage lifecycle changes, renewals and post‑approval commitments
  • Maintain regulatory data in RIMS and dashboards
  • Lead regional hub coordination with dealers and consultants
  • Integrate AI‑enabled tools to improve submission efficiency

What you’ll bring

  • 7+ years regulatory affairs experience in healthcare/medical device industry
  • Hands‑on APAC submission experience
  • Knowledge of EU MDR, US FDA, MDSAP regulations
  • Experience with RIMS (Veeva RIM, Ennov, TrackWise, MasterControl)
  • Ability to manage multi‑country regulatory projects

Skills

Regulatory strategyAPAC submissionsRIMS data managementEU MDR complianceUS FDA pathwaysMDSAP auditsAI‑enabled documentationCross‑functional collaboration

Education

Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy or related discipline

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