Purpose of the Job

The purpose of this job is to ensure that products comply with all applicable regulatory requirements and standards throughout their lifecycle, supporting secure, timely, and compliant market access.

Tasks, Roles and Responsibilities
Product Portfolio Analysis (Healthcare – MED, RMS, IQS, Vision)
Analyze the product portfolio under the healthcare domain to determine regulatory pathways, classification, and applicable Indian regulations and standards.
Registrations as Importer / Manufacturer
Arrange, compile, and maintain all required documents for registration of products and entities as importer and/or manufacturer with the relevant authorities.
Coordinate with internal stakeholders and external partners to ensure complete and accurate dossiers.
Regulatory Liaison (Authorities)
Liase with Regulatory authorities for product registration and clarifications.
Licenses for Distribution (Drug Sale License / Registration Certificate)
Obtain and maintain Drug Sale Licenses / registrations required for the distribution of medical devices.




Coordinate with distributors and channel partners to ensure they hold appropriate licenses and registrations.
Compliance with License and Registration Conditions
Ensure full compliance with all terms and conditions of licenses, registrations, and approvals.
Periodically review license status, validity, and scope; initiate renewals and amendments in time.
Labeling and Pre‑marketing Approvals
Review and approve product labeling, IFUs, packaging artwork, and pre‑marketing materials for compliance with Indian regulatory requirements and granted approvals.
Verify that claims, indications, and mandatory information are accurate and consistent.
BIS, MOEF, ETA Approvals
Arrange and coordinate necessary documentation and testing for obtaining BIS certifications, MOEF-related approvals (e.g., for e‑waste/environmental compliance), and ETA (equipment type approval) where applicable.
Maintain records of all certifications and ensure

📌 Regulatory Specialist (Bengaluru)
🏢 Zeiss India
📍 Bengaluru