Regulatory Affairs Professional

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Regulatory Affairs Professional

Location(s): Issaquah, WA

(Hybrid)

• 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.

• 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.

• Bachelor's degree (preferably in science, engineering, or related field).
• At least 5 years of China NMPA registration experience in the medical ultrasound industry.
• Strong knowledge of China NMPA regulations and standards.
• Experience with regulatory compliance documentation.
• Ability to work onsite in Issaquah.
• Mandarin language skills preferred.

• A self-starter with proven regulatory experience and a collaborative mindset.
• Able to meet deadlines, handle shifting priorities, and communicate clearly across teams.
• Familiar with global medical device manufacturers is a plus.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.