Regulatory Affairs Specialist China NMPA (Ultrasound Imaging)

Overview

Remote

Hybrid

$50 - $60

Contract - W2

Contract - 3 Month(s)

Skills

NMPA

Regulations

Medical devices

Job Details

Job Description

Position Title: Regulatory Affairs Specialist China NMPA (Ultrasound Imaging)
Location: Hybrid/Remote Issaquah, WA preferred
Duration: 3 6 Month Contract
Pay Rate: Up to $60/hour
Industry: Medical Devices Ultrasound Imaging

Position Overview:

We are seeking a contract Regulatory Affairs Specialist with proven experience supporting China NMPA registration for medical devices, ideally in the ultrasound imaging space. This role will focus on preparing and compiling regulatory submissions in compliance with Chinese regulations, in close collaboration with cross-functional teams. You ll play a critical part in enabling market access for innovative diagnostic technologies in China.

Key Responsibilities:

Prepare and compile regulatory submission packages for ultrasound imaging devices in alignment with China NMPA requirements.
Coordinate with internal teams (RA, R&D, Clinical, Marketing) to gather necessary technical, clinical, and compliance documentation.
Review and maintain technical files, CERs, and other documentation to meet regulatory standards.
Track submission status and timelines; liaise with China-based agents or legal reps as needed.
Maintain accurate records and documentation to support audits or regulatory inquiries.

Qualifications:

Bachelor s degree or higher in a scientific, engineering, or medical field.
Minimum 3 years of direct experience with China NMPA registration for medical devices.
Strong understanding of Chinese regulatory standards, clinical evaluation requirements, and submission procedures.
Experience preparing and managing regulatory dossiers, technical documentation, and CERs.
Detail-oriented with strong documentation and organizational skills.
Mandarin language skills preferred for reviewing documents and communicating with stakeholders.
Must be located in or willing to work on Pacific Time with availability for evening calls with China.
Ability to work onsite 2 3 days/week in Issaquah, WA is preferred but remote candidates will also be considered.

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