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.
...Home Manager Full-Time Charlottesville, VA Are you highly organized, proactive, and love keeping things running smoothly? Were looking for a Home Manager to join our household team and help create a supportive, welcoming environment. This role blends childcare...
...Servicenow Developer Title: ServiceNow Developer Duration: 6 12 month contract-to-hire Location: Chicago, IL (hybrid) Must Have: Strong ServiceNow developers with experience in building out service catalogue, get through knowledge migration, etc. Experienced in ServiceNow...
...is seeking to hire a full-time Retail Sales Associate / Device Repair Technician to provide top-notch customer service while making... ...recommend the right battery for the application whether it's a cell phone, truck, or recreational vehicle. You also answer inbound phone...
...family-owned and operated, working farm and agritainment destination in the heart of Lancaster County. What started as the "farm with a corn maze," has grown into a nationally recognized experience, best known for an award-winning corn maze and more than 60 family-friendly...
...Description Company Overview At Catapult Learning, we provide educational solutions that generate academic achievement and better life... ...pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic...