Regulatory Affair Executive

9 hours ago


Odhav Approach Ahmedabad, India Sigma Surgical Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Key Responsibilities:

  • Ensure products meet all local and international regulatory requirements
  • Prepare, review, and submit regulatory documents including dossiers, technical files, and product registrations
  • Communicate with regulatory agencies to obtain approvals and resolve queries
  • Manage regulatory aspects of product changes (formulation, packaging, labeling)
  • Assist in regulatory audits and inspections by providing necessary documentation and support
  • Obtain and maintain licenses and approvals for products across various markets
  • Stay updated on changes in regulatory guidelines and ensure company compliance
  • Collaborate with R&D, QA, and Production teams to ensure regulatory compliance throughout the product lifecycle
  • Maintain and update technical files and EU Declaration of Conformity
  • Provide regulatory guidance to other departments for product launches and modifications
  • Ensure post-market surveillance and vigilance requirements are met
  • Must Knowledge of ISO 13482

Qualifications & Skills:

  • M.Pharm in R.A.
  • Min. 2 of experience in Regulatory Affairs (preferably in Medical Equipment)
  • Strong understanding of regulatory frameworks (e.g., FDA, EU MDR, CDSCO)
  • Excellent documentation and communication skills
  • Ability to work cross-functionally and manage multiple projects


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