2–3 days in-office preferred. Overlap with China hours; Pacific Time Zone preferredDescription: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 client, with some flexibility for time zone coordination.Ideal Candidate: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 the client systems or similar global medical device manufacturers is a plus.Must-Have Skills1. Bachelor’s degree (preferably in science, engineering, or related field).2. At least 5 years of China NMPA registration experience in the medical ultrasound industry.3. Strong knowledge of China NMPA regulations and standards.4. Experience with regulatory compliance documentation.5. Ability to work onsite in client.6. Mandarin language skills preferred.Notes:2–3 days in-office preferred. Overlap with China hours; Pacific Time Zone preferred. VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description: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 client, with some flexibility for time zone coordination.Ideal Candidate: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 the client systems or similar global medical device manufacturers is a plus.Must-Have Skills1. Bachelor’s degree (preferably in science, engineering, or related field).2. At least 5 years of China NMPA registration experience in the medical ultrasound industry.3. Strong knowledge of China NMPA regulations and standards.4. Experience with regulatory compliance documentation.5. Ability to work onsite in client.6. Mandarin language skills preferred.Notes:2–3 days in-office preferred. Overlap with China hours; Pacific Time Zone preferred.
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