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.
Our Norwalk, CT client is growing their business and looking to add a Human Resources Administrator to their team. This position offers a salary in the $70k-$80k plus fabulous benefits and a hybrid work schedule. Responsibilities include: Process multi-state...
IronRoad is conducting a confidential search for a full-time hourly Commercial Property Management Maintenance Technician ($23.00 - $25.00 per hour based on candidates' skill & experience) focused on Building Maintenance for a Property Management Company. This is a direct...
...Job Description: We are seeking a highly skilled and detail-oriented Consultant Statistician/Programmer to support Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) initiatives. The successful candidate will work closely with the RWE/HEOR...
...working with a well-established South Jersey boutique law firm to find an associate attorney with 5+ years of experience in special education law to advise public school clients. Must have strong knowledge of IDEA, Section 504, and ADA, and experience representing schools...
...Backcountry, our mission is to connect people to their passions. Our four online storesBackcountry, Competitive Cyclist, MotoSport and,... ...policies available Company 401K match Company Health Spending Account (HSA) match Company provides group life insurance...