Documentation Officer

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