Documentation Specialist

Job Overview

We are seeking a skilled Documentation Specialist to join our team.

The successful candidate will be responsible for creating, maintaining and updating technical documentation related to medical devices.

This role requires a strong understanding of ISO standards and regulatory requirements for the medical device industry.

Key Responsibilities:

• Develop and maintain high-quality technical documents in accordance with ISO standards.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
• Support the preparation and maintenance of documents required for regulatory submissions.
• Maintain accurate quality records and ensure traceability as per ISO 13485 guidelines.

Requirements:

• Bachelor's degree in a relevant field such as engineering or science.
• Minimum 2 years of experience in medical device documentation.
• Strong knowledge of ISO standards and regulatory requirements for medical devices.
• Excellent communication and organizational skills.