Immunodiagnostic Documentation Specialist

10 hours ago


Ajmer, Rajasthan, India beBeeDocumentation Full time ₹ 8,00,000 - ₹ 12,00,000
Job Title: Immunodiagnostic Documentation Specialist

We are seeking a skilled professional to develop and maintain clear, accurate, and compliant documentation for immunodiagnostic products.

Key Responsibilities:

  • Create and edit high-quality technical content (IFU, DFU, labels, manuals, quick-start guides, digital aids).
  • Translate complex scientific/regulatory information into clear, user-centric documentation.
  • Ensure compliance with regulatory requirements including IVDD/IVDR, FDA 21 CFR Part 11, and ISO 13485 standards.
  • Collaborate effectively with cross-functional teams.
  • Contribute to the continuous improvement of documentation standards and processes.

Qualifications:

  • Experience in technical writing for life sciences/medical devices.
  • Strong knowledge of regulatory documentation requirements.
  • Excellent writing, editing, and collaboration skills.

The Ideal Candidate:

  • Will have a strong background in technical writing.
  • Will possess excellent communication skills.
  • Will be able to work collaboratively as part of a team.
  • Will be able to take complex scientific information and turn it into clear, concise, and easy-to-understand documentation.


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