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About Company

TACIT MEDTEK is a support/service company located in Sadar, specializing in facilitating companies in the field of medical devices and In-Vitro Diagnostics. The company focuses on quality and consistency in regulatory dossier compilation and support services, including CE Technical File Preparation, US FDA 510K filing, ISO 13485 Implementation, India Approvals for medical devices/IVDs, and regulatory filings in various markets.

Position Name :

Regulatory Affairs Executive

Organization :

TACIT MEDTEK

Qualification:

B.Pharm, M.Pharm, Msc, BSc

Experience:

0 YEARS / Freshers

Salary:

25,000 - 35,000 /month

Location:

Gautam Buddha Nagar, Uttar Pradesh, India

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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