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.
...contract with extensions Pay: 20-22/hr Shift: Ranging from 2-11pm Requirements: ~ Bachelors degree ~ Experience with research or following work processes (gathering requirements, capturing notes, documentation). Any clinical experience can work as well....
...(DLTS) located in Tempe, Arizona is currently looking for a Project Manager who is experienced in commercial Structured Cabling and similar... ..., proposals, presentations, and negotiations # Administers contract terms and conditions, contract documents, subcontract...
...Environmental / Safety Manager &##128205; Location: Chattanooga, TN (relocation assistance provided) &##128197; Schedule: Monday Friday... .... Qualifications: Bachelors degree in Environmental Science, Safety, Engineering, or related field (or equivalent...
...cart. Foster a guest-obsessed culture that prioritizes the guest experience and delivers on sales goals. Oversee the mystery shop and NPS programs to deliver a memorable guest experience in each location. Manage teams of hourly team members, interviewing, developing...
...Minimum of 2 years of industrial experience in a Quality Control laboratory setting. A degree (BS or BA) in Biology, Chemistry, Biochemistry, or a related field, or sufficient professional experience in lieu of a technical degree. Experience with pharmaceutical...