Documentation Officer

Polymed

1 - 6 years

3 - 5 Lacs

ballabhgarh

Posted:-1 days ago| Platform:

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Skills Required

documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Department:

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 hrd7@polymedicure.com

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