Job Description

At-a-Glance:
Are you ready to build your career by joining a multi-national medtech company? If so, our client is hiring a Regulatory Affairs Specialist - China NMPA (Ultrasound Imaging).


Position Type:

• Contract
• Hybrid or Remote - 2-3 days in office preferred.

Required:

• Bachelor's degree or above in a scientific, engineering, or medical discipline.
• Minimum 3 years of direct experience with China NMPA registration for medical devices, preferably ultrasound.
• Solid understanding of NMPA regulations, clinical evaluation requirements, and applicable standards.
• Experience in preparing and managing regulatory documents (e.g., technical files, CERs, product dossiers).
• Strong organizational and documentation skills with attention to detail.
• Mandarin Chinese language proficiency preferred for working with Chinese documentation and stakeholders.
• Ability to work remotely or in a hybrid setup from Issaquah, WA, with some flexibility for time zone coordination.
• A self-starter with proven regulatory experience and a collaborative mindset.
• Able to meet deadlines, handle shifting priorities, and communicate clearly across teams.
• Familiar with global medical device manufacturers is a plus.

Responsibilities:

• Prepare and compile regulatory submission documents for ultrasound imaging devices in accordance with China NMPA requirements.
• Coordinate with internal teams (RA, R&D, Clinical, and Marketing) to gather technical, clinical, and compliance documentation.
• Ensure accuracy and completeness of technical files and CERs (Clinical Evaluation Reports) per Chinese regulatory standards.
• Track submission timelines and support communication with local agents or legal representatives, if applicable.
• Maintain clear records of documentation and submission status to support regulatory audits or inquiries.

Get in Touch:
If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more.

#LI-SG1
#HbM6349 Hired by Matrix

Job Tags

Contract work, Local area, Remote job, Shift work,

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