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.
...Kelly is seeking a field service technician that would service a solar site in Andrews, TX Position is a long term contract role (... ..., maintenance, warranty remediation and commissioning for installed photovoltaic inverters, energy storage, plant controls, DC, panels...
Alibaba operates hyper-scale networks that serve hundreds of millions of users around the world. Alibaba Infrastructure Service(AIS) Networking Team is responsible for keeping the network running reliably, efficiently and at scale. We are looking for experienced and passionate...
...seeking a full-time Member Services Representative (MSR) to join their growing team. This is an excellent opportunity for someone with banking or financial services experience who thrives in a customer-first environment and is passionate about community involvement....
...computer/iPad Requirements Class A CDL license Medical Card (company will... ...Plan with multiple investment options ~ Training and Development Programs ~ Employee... ...employees to realize their full potential, and drives high performance through innovation and...
...tight-knit facilities team supporting a high-quality commercial building in Kent, WA, where your expertise directly impacts tenant... ...to support a high-profile property with a focus on day-to-day maintenance, preventative programs, and responsive tenant service. This is...