Documentation Officer

2 weeks ago

ballabgarh, India Poly Medicure Ltd Full time

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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