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.
- 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 Environment, 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 approvals.
- Periodically review license status, validity, and scope; initiate renewals and amendments in time.

- Labeling and Premarketing Approvals
- Review and approve product labeling, IFUs, packaging artwork, and premarketing 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 ewaste/environmental compliance), and ETA (equipment type approval) where applicable.
- Maintain records of all certifications and ensure timely renewal.
- Application Tracking and Query Management
- Track status of all regulatory applications and licenses on respective portals and through direct communication with authorities.
- Respond to regulator queries, clarifications, and deficiency letters within defined timelines, coordinating input from relevant functions.
- Regulatory Intelligence & Change Management
- Continuously monitor changes in Indian and SAARC regulations, guidance documents, standards, and notifications impacting the product portfolio.
- Assess impact of regulatory or internal product/process changes and drive implementation (gap analysis, action plans, training, document updates).

Key Requirement/Minimum Eligibility:

- Ability to work alone with minimal supervision.

Ability to analyze and interpret technical information

📌 Regulatory Specialist (Bengaluru)
🏢 Zeiss
📍 Bengaluru