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.
- Strong understanding of relevant regulations and standards.
- Strong 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