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.
...Logistics & Inventory Specialist Supplementary to the duties of a warehouse operative, you are involved in logistical planning and operational processes. Planning, scheduling, organizing and controlling all inventory-related activities in accordance with legislative requirements...
Supply Room Clerk Summary: The supply room clerk maintains inventory of spare parts for the plant. The position is a M F, 8am 4pm, 40 hour/week job with occasional overtime required. Must be a U.S. Citizen, as this job is within a Secured Facility. Duties...
Returning Users Log Back In Role Overview Sodexo is seeking a full-time Dietitian Nutritionist to support the Inpatient Medical Nutrition Department at Methodist Hospitals. This position offers a great opportunity to grow and enhance your clinical skills by working...
...The UX/UI Web Designer will be responsible for crafting intuitive, visually compelling, and brand-aligned digital experiences that elevate the luxury e-commerce journey on . They will translate the brands high-end aesthetic and values into elegant, user-centered...
...including but not limited to assisting in the administration of medication, checking of vitals and crisis intervention.? Engage with... ...abstinence from alcohol and/or drugs. 6. Maintain CPR and First Aid certification card on file. 7. Bi-lingual/Bi-cultural preferred...