Contract Position: Regulatory Affairs Specialist – China NMPA (Ultrasound Imaging)
Location: Hybrid/Remote (Issaquah, WA preferred)
Duration: 3-6
Industry: Medical Devices – Ultrasound Imaging
Job Summary:
We are seeking a Regulatory Affairs Specialist (Contractor) with hands-on experience in China NMPA registration for ultrasound imaging devices. This role will support the preparation and compilation of regulatory submissions to ensure timely product approvals in China. The ideal candidate will be detail-oriented, well-versed in NMPA regulations, and capable of working independently in a fast-paced, cross-functional environment.
Key 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.
Qualifications:
• 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.
...everything we do: We Have Commitments, We Think Big, We Act as Owners, We're People Too, and We Never Settle. ABOUT THE ROLE The Director of Golf Sales will be responsible for strategically leading and executing Mizzen+Main's sales initiatives within the golf market. This...
Were looking for a Senior UX Designer with strong end-end UX experience from information architecture to visual design across both mobile and desktop user experiences. Responsibilities: Lead mobile/desktop UX design. Develop roadmaps and drive projects from...
Job DescriptionGardaWorld Security Services is Now Hiring a Surveillance Security Officer!Ready to suit up as a Surveillance Security Guard?What matters most about a role like this is your sharp eye, capturing every detail as you scan a series of screens. Tell us about...
...one story at a time.We are without a doubt one of the most premier retirement community and is a dream come true for an experienced Chef. At a Watermark Community our chef does so much more than what the title reflects. For us it is about working with Chefs who agree...
...Job Description Job Description JOB DESCRIPTION COPYWRITER Creative Department Job Summary A Copywriter displays an intermediate level of competency in their core function as demonstrated through on-the-job or previous agency experience. They are...