Requirements

Education
Bachelors degree in life sciences, engineering, pharmacy, or related field; advanced degree is a plus.
Experience - 4 to 7 years of experience in Regulatory Affairs

Other skills
Read, write, and communicate in English (must).
Preferably knows the local language.
Robust understanding of relevant regulations and standards.
Robust attention to detail, organizational skills, and ability to manage multiple projects.
Proficiency with standard office tools; experience with regulatory or document management systems is a plus.
In-depth understanding of medical device regulations which includes but not limited to the followings,
The Drugs & Cosmetics Rules
The Medical Device Rules
The Legal Metrology Act and Rules
AERB Regulations
BIS Standards
Ministry of Workplace, Forest and Climate Change (MoEFCC)
SAARC Regulations
ETA

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

📌 Regulatory Specialist Bengaluru
🏢 Zeiss
📍 Bengaluru