Documentation Specialist

10 hours ago


Mumbai, Maharashtra, India beBeeDocumentation Full time ₹ 10,00,000 - ₹ 17,50,000

Job Title: Documentation Specialist

Role Overview:

We are seeking a skilled documentation specialist to develop and maintain high-quality, accurate, and compliant documentation for immunodiagnostic products.

This role involves creating technical content including instructions for use (IFU), device information files (DFU), labels, manuals, quick-start guides, and digital aids. The ideal candidate will have excellent writing and editing skills, as well as the ability to collaborate with cross-functional teams.

Key Responsibilities:
  1. Create clear and concise technical content that meets regulatory requirements.
  2. Collaborate with Product Development, Regulatory, QA, Marketing, and Operations teams to ensure compliance with IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and internal quality standards.
  3. Develop and maintain documentation standards and processes to improve efficiency and quality.
  4. Contribute to the development of training materials and programs to support staff in understanding and implementing documentation standards.
Required Skills and Qualifications:
  • Experience in technical writing for life sciences/medical devices.
  • Strong knowledge of regulatory documentation requirements.
  • Excellent writing, editing, and collaboration skills.

The successful candidate will be a self-motivated and detail-oriented individual who is able to work independently and collaboratively as part of a team. They will have a strong understanding of regulatory requirements and documentation best practices.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for documentation and regulatory compliance, we encourage you to apply for this exciting opportunity.

About Our Team:

We are a dynamic and collaborative team dedicated to delivering high-quality products and services to our customers. We value innovation, teamwork, and continuous improvement, and we are committed to providing our employees with a positive and supportive work environment.



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