Regulatory Specialist

ZEISS India; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

ZEISS India seeks a Regulatory Affairs professional to ensure product compliance across lifecycle, enabling timely market access in line with Indian regulations. The role focuses on registrations as importer/manufacturer, dossier preparation, and liaison with authorities while maintaining licenses, labels, and pre‑marketing materials for the medical devices portfolio.

You will monitor regulatory changes and coordinate with internal teams and external partners to sustain documentation and

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy, or related field.
• Experience - 4 to 7 years of experience in Regulatory Affairs.
• Read, write, and communicate in English (must).
• Ability to work alone with minimal supervision.
• Ability to analyze and interpret technical information.
• 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 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

Responsibilities

• Analyze the regulatory pathways, classification, and Indian regulations and standards for the healthcare portfolio.
• Registrations as Importer / Manufacturer.
• Arrange, compile, and maintain documents for registration with relevant authorities.
• Coordinate with internal stakeholders and external partners to ensure complete dossiers.
• Liaise with Regulatory authorities for product registration and clarifications.
• Obtain and maintain Drug Sale Licenses / registrations for distribution of medical devices.
• Coordinate with distributors and channel partners to ensure license compliance.
• Compliance with License and Registration Conditions.
• Review labeling and pre‑marketing materials for compliance with Indian requirements and approvals.
• Verify claims, indications, and mandatory information.
• Arrange documentation and testing for BIS, MOEF, ETA approvals; maintain certificates.
• Track regulatory applications and respond to regulator queries.
• Regulatory Intelligence & Change Management

Skills

English proficiency

Independent work

Analytical skills

Regulatory knowledge

Documentation tools

Medical device regs

Education

Bachelor’s degree in life sciences, engineering, pharmacy, or related field

Tools

MS Office

Regulatory document systems

Job description

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

Tasks, Roles and Responsibilities

• 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.
• Liase with Regulatory authorities for product registration and clarifications.
• 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 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).

Requirements

Education

• Bachelor’s 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).
• Ability to work alone with minimal supervision.
• Ability to analyze and interpret technical information.
• 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 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