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 Job Description CN Tommell LLC is looking for an experienced heavy truck and trailer mechanic to repair and maintain our truck fleet along with our farm equipment at our Voorheesville location. If you are looking for something different, we offer a...
...Job Title:UI/UX Designer Duration: 6 Months (Possible Extension) Location:Jersey City, NJ ***Due to client requirements this role is only open to USC or GC candidates*** No C2C Job Summary: Requirements: ~6+ years of experience in web or digital...
...Scrum Master Bloomfield, CT (Onsite from Day 1) Long Term Contract Skills req: Agile, Scaled Agile, Healthcare Key Responsibilities: Facilitate Scrum ceremonies and ensure adherence to agile principles. Coordinate project activities, resources, and...
...Description TTF Healthcare is recruiting for a full-time Front Office Medical Assistant for a well-respected specialty practice in Scottsdale... ...to place MA's, Medical Assistants, Front Office Specialists, Back Office Specialists, Medical Records, Surgery Schedulers, and...
...for a compassionate Dentist to join our collaborative team of dental professionals. Enjoy the support of experienced colleagues while... ...Art shows, Museum of Art REFERENCE NUMBER: 199688 ABOUT DELTA PHYSICIAN PLACEMENT Delta Physician Placement (DPP), the permanent...