Immunodiagnostic Documentation Specialist

1 day ago

Belgaum, Karnataka, India beBeeDocumentation Full time US$ 60,000 - US$ 70,000

Technical Documentation Specialist

Job Description:

As a skilled technical documentation specialist, you will develop and maintain clear, accurate, and compliant documentation for immunodiagnostic products. Your primary responsibility will be to create high-quality technical content, including IFU, DFU, labels, manuals, quick-start guides, and digital aids.

  • Create and edit high-quality technical content, including user manuals, quick-start guides, and instructional materials.
  • Translate complex scientific and regulatory information into clear, user-centric documentation.
  • Ensure compliance with relevant regulatory standards, such as IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and internal quality standards.
  • Collaborate with cross-functional teams, including product development, regulatory, QA, marketing, and operations.
  • Contribute to the continuous improvement of documentation standards and processes.

Key Responsibilities Include:

  1. Developing and maintaining technical documentation that meets regulatory requirements and customer needs.
  2. Working closely with subject matter experts to ensure accuracy and completeness of documentation.
  3. Staying up-to-date with industry developments, regulatory changes, and best practices in technical documentation.
  4. Collaborating with internal stakeholders to align documentation with business goals and objectives.
  5. Providing training and support to internal teams on documentation standards and procedures.
Required Skills & Qualifications:
  • Bachelor's degree in a related field, such as English, Communications, or Technical Writing.
  • Proven experience in technical writing and documentation management.
  • Strong understanding of regulatory requirements, such as IVDD/IVDR and FDA 21 CFR Part 11.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and projects.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a talented team of professionals in a dynamic industry.
  • Professional growth and development opportunities.

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