Assistant Manager / Officer - Documentation

Role & responsibilities

Department: R&D
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.

Interested can share their CV with [email protected]