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.
...Training, Pension, AND Paid Overtime Service recognition and employee rewards Excellent Leadership EXCELLENT BENEFITS: Medical, dental, vision, Pension Plan, and Employee Stock Purchase Plan (ESPP) life insurance. Main Ingredients of the Job As a...
...Compensation: Full-time, Non-Exempt $33.77/hr Comprehensive Benefits including Health, Life Insurance, STD, 401(k) plan and more! Company Information: ARG is the longest continuously operating refinery in North America dating back to 1881. Privately held, the...
...As a Director of Sales , you bring high-energy, customer-centric focus and drive/hunger to the total sales efforts of the hotel. In other words, you get paid to make relationships! Salary Range $77,000 - $82,000 You are eligible for quarterly bonuses, get paid time...
...administrative functions in thebusiness office of a 27 year-old commercial construction company. Prior experience in construction... ...Family-owned business for 27 years, specializing in commercial roofing and general construction. Company Description Family-owned...
...We are looking for a highly skilled Data Modeler with expertise in data modeling techniques , Erwin , ETL processes , and Google Cloud Platform (GCP) . The ideal candidate will be responsible for designing and implementing efficient data models that support data...