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 [HIDDEN TEXT]