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.
- Positive 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]

📌 Assistant Manager / Officer - Documentation (Ballabhgarh)
🏢 Polymed
📍 Ballabhgarh