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TACIT MEDTEK

0 YEARS / Freshers

25,000 - 35,000 /month

Gautam Buddha Nagar, Uttar Pradesh, India

B.Pharm, M.Pharm, Msc, BSc

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

This is a full-time, on-site role for a Regulatory Affairs Executive at TACIT MEDTEK. The Regulatory Affairs Executive will be responsible for:

  • Regulatory Documentation: Ensure accurate and complete regulatory documentation.
  • Meeting Regulatory Requirements: Stay up-to-date with the latest regulatory requirements.
  • Regulatory Compliance: Ensure compliance with regulatory standards and guidelines.
  • Dossier Preparation: Prepare comprehensive and well-organized regulatory dossiers.
  • Regulatory Affairs Processes: Have a strong understanding of regulatory affairs processes and procedures.
  • Handling Queries and Amendments: Manage queries and post-approval amendments.
  • Market Intelligence: Provide market intelligence and support ISO 13485 site audits and compliance.

Qualifications

  • Regulatory Documentation: Proven ability to ensure accurate and complete regulatory documentation.
  • Regulatory Requirements: Knowledge of the latest regulatory requirements.
  • Regulatory Compliance: Experience in ensuring compliance with regulatory standards and guidelines.
  • Dossier Preparation: Competency in preparing comprehensive and well-organized regulatory dossiers.
  • Regulatory Affairs: Strong understanding of regulatory affairs processes and procedures.

Skills

  • Regulatory Requirements
  • Regulatory Affairs
  • Dossier Preparation
  • Compliance
  • Market Intelligence
  • ISO 13485 Audits
  • Post-approval Amendments

Application Link

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