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.
...Job Description vArida-Tech Inc. is seeking a local contract nurse RN Labor and Delivery for a local contract nursing job in Newport, Vermont. Job Description & Requirements ~ Specialty: Labor and Delivery ~ Discipline: RN ~ Start Date: ASAP ~ Duration...
Greencroft Communities is seeking a Marketing Coordinator to join our corporate Marketing team!In this role, you'll serve as the hub for marketing project coordinationmanaging timelines, collaborating with internal teams and vendors, and assisting with design to ensure...
...Operator is responsible for managing all inbound and outbound calls received by the main Switchboard/Private Branch... ...~ High School graduate or equivalent (GED)~1 year of experience in Customer Service, Call Center, and/or Healthcare What Would Be Nice To Have:...
...WASHINGTON STATE CHARTER SCHOOLS ASSOCIATION JOB DESCRIPTION: Director of Communications and Branding Place of Performance : Remote (occasional in-person meetings) Supervisor : Executive Director Direct Reports : Status : Full Time, Exempt Travel Requirements...
...San Jose location. Minimum Qualifications: ~ Fully fluent, written and verbal, in English and Cantonese, writing in Traditional Chinese ~ Excellent written and verbal communication skills ~ Ability to clearly explain linguistic challenges and cultural questions...