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Immunodiagnostics Documentation Specialist

2 weeks ago

Nellore, Andhra Pradesh, India beBeeDocumentation Full time ₹ 60,00,000 - ₹ 90,00,000

Documentations Specialist

  • We are seeking a Documentations Specialist to develop and maintain clear, accurate, and compliant documentations for immunodiagnostic products.
  • The ideal candidate will translate complex scientific/regulatory information into clear, user-centric documentations.
  • The selected candidate will ensure compliance with regulatory requirements and internal quality standards.
  • Collaboration with cross-functional teams is necessary to create high-quality technical content.
  • The Documentations Specialist will contribute to continuous improvement of documentation standards and processes.
Responsibilities:
  1. Develop and edit high-quality technical content including IFUs, user manuals, product labels, and digital learning aids.
  2. Translate complex scientific/regulatory information into clear, user-centric documentations.
  3. Ensure compliance with IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and internal quality standards.
  4. Collaborate with Product Development, Regulatory, QA, Marketing, and Operations teams.
  5. Contribute to continuous improvement of documentation standards and processes.
  • Experience in technical writing for life sciences/medical devices.
  • Strong knowledge of regulatory documentation requirements.
  • Excellent writing, editing, and collaboration skills.

What We Offer:

  • A competitive compensation package.
  • A dynamic work environment.
  • Ongoing training and professional development opportunities.
  • Access to state-of-the-art technology and equipment.
  • A comprehensive employee wellness program.

About This Role:

This role requires a strong background in technical writing and experience in the medical device industry.

The successful candidate will have excellent writing, editing, and collaboration skills, as well as proficiency in MS Office and the ability to learn new tools quickly.

Strong attention to detail and organizational skills are necessary, along with the ability to work in a fast-paced environment and meet deadlines.

Effective communication and interpersonal skills are required, along with a Bachelor's degree in English, Communications, or a related field.