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.
...Graphic Design Intern - Architecture & Construction Position Overview We are seeking a creative and motivated Graphic Designer Intern to join our architecture and construction team. This role offers hands-on experience creating visual communications that support...
Join to apply for the Spanish Interpreter - Flexible Schedule role at Burnes Home Accents .Language World is a leading language solutions provider... ...listening, speaking, and retention skills.Experience with medical terminology.Promptly submit administrative and timekeeping...
...Health System is seeking a BC/BE Orthopedic Spine Surgeon to join its team in Grand Forks, ND. ~ Team of 5 surgeons ~5 orthopedic surgery APPs ~ M-F with 1 OR day to start, can move over time to 2 OR days with 1:6 weekend only call ~ Dedicated core staff in the...
...Out Mentality: Adapt, innovate, and execute with precision. Servant Leadership: Help your team shine. Title: Field AV Engineer Department: Operations Reports To: Vice President of Customer Success Position purpose and objective: This...
...people to thrive. Keeley Companies is looking for a Marketing Intern to join our Marketing Team in Summer 2026. Primary Responsibilities Marketing and... ...Session at end of summer to provide feedback on internship experience. Minimum Qualifications In the...