
Documentation Officer
4 days ago
Role & responsibilities
Department: R&D(Documentation)
Experience: Minimum 2 Years
Qualification: B.Tech / B.Pharma
Key Responsibilities:
- Prepare, maintain, and update documentation related to Design Input, Design Output, and Technical Files.
- Ensure documentation compliance with ISO standards applicable to medical devices.
- Support in preparation and maintenance of documents required for regulatory submissions.
- Collaborate with cross-functional teams to gather and validate information for technical documentation.
- Maintain and control quality records, ensuring traceability and accuracy as per ISO 13485 and related guidelines.
- Assist in internal and external audits by providing required documentation.
Required Skills & Competencies:
- Strong knowledge of ISO standards ( ISO 13485).
- Hands-on experience in medical device documentation.
- Good understanding of regulatory requirements for medical devices.
- Excellent attention to detail, organizational, and communication skills.
- Proficiency in MS Office and documentation management tools.
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