Regulatory Specialist

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