Job description:

Documentation for Chinese Regulatory Approval: Prepare development deliverables for ultrasound products developed in Korea to secure regulatory certification in China.

Includes: Project initiation, phase-by-step development planning, verification documents, etc.

Project Management: Manage ultrasound imaging diagnostic medical device development projects and execute phase-specific development documentation.

Compliance & Technical File Management: Manage development history and technical documentation (Technical Files) to support product licensing and regulatory requirements.

Ultrasound Medical Device Project Management: Oversee schedules, deliverables, and quality control.

Documentation Lifecycle Management: Create and manage output documents for each stage of the development process.

Cross-functional Collaboration: Partner with relevant departments to respond to regulatory demands and operate development processes effectively.

Qualifications:

Experience in Ultrasound Development: Proven track record in ultrasound diagnostic device development or commercialization.

Technical Writing Expertise: Experience in creating development deliverables such as the Design History File (DHF).

Leadership: Experience leading ultrasound development projects (as a Project Leader or equivalent role).

Language Proficiency: Fluency in both Korean and Chinese.

Technical Knowledge: Deep understanding of the operating principles and functions of ultrasound imaging diagnostic devices.

Process Knowledge: Strong understanding of medical device development processes and standard operating procedures.

Why is This a Great Opportunity:

This is a great opportunity to work locally in China

Salary Type : Annual Salary

Salary Min : N/A 60000

Salary Max : N/A 80000

Currency Type : N/A