
Documentation Specialist
10 hours ago
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:- Create clear and concise technical content that meets regulatory requirements.
- 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.
- Develop and maintain documentation standards and processes to improve efficiency and quality.
- Contribute to the development of training materials and programs to support staff in understanding and implementing documentation standards.
- 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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