Regulatory Specialist

ZEISS; Bengaluru; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

ZEISS in Bengaluru, India seeks an experienced Regulatory Affairs professional to steer registrations for healthcare devices and ensure compliance with Indian rules. The role involves classifying products, coordinating importer/manufacturer registrations, and liaising with authorities to obtain and renew licenses.

The candidate should have 4–7 years in Regulatory Affairs, strong English communication, and familiarity with global regulatory trends.

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy, or related field.
• 4–7 years of experience in Regulatory Affairs.

Responsibilities

• Product Portfolio Analysis to determine regulatory pathways for Healthcare MED, RMS, IQS, Vision.
• Prepare and maintain dossiers for importer/manufacturer registrations with authorities.
• Regulatory liaison with authorities for product registrations and clarifications.
• Coordinate licenses for distribution (Drug Sale License/Registration Certificate).
• Track regulatory applications and respond to queries within timelines.
• Monitor changes in Indian and SAARC regulations and drive implementation.

Skills

English communication

Regulatory knowledge

Project coordination

Attention to detail

Regulatory liaison

Education

Bachelor's degree in life sciences/engineering/pharmacy

Tools

Regulatory/document management systems

Job description

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 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