Regulatory Affairs Specialist

Net2Source Inc.; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

Net2Source Inc. is seeking a Regulatory Affairs Professional 2 with expertise in the medical ultrasound industry. In this remote role, you will prepare regulatory submission documents compliant with China NMPA standards, coordinate internal documentation efforts, and maintain records for audits. This position requires a bachelor's degree in a related field and offers a flexible work schedule within the Pacific Time Zone.

Qualifications

• Minimum 3 years experience in regulatory affairs.
• 5 years China NMPA registration experience in medical ultrasound.
• Strong knowledge of China NMPA regulations and standards.

Responsibilities

• Prepare and compile regulatory submission documents for ultrasound imaging devices.
• Coordinate with internal teams to gather technical and compliance documentation.
• Ensure accuracy of technical files and support communication with local agents.

Skills

Regulatory compliance documentation

Knowledge of China NMPA regulations

Strong communication skills

Education

Bachelor's degree in science or engineering

Job description

This range is provided by Net2Source Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $60.00/hr

Direct message the job poster from Net2Source Inc.

US Staffing Technical Recruiter at Net2Source

Job Title: Regulatory Affairs Professional 2

Location: Remote -Pacific Time Zone preferred

Work Hours: Flexible, but must be available for evening calls with China.

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.

Travel: Not required.

Experience Required: Minimum 3 years.

Start Timeline: ASAP .

Must-Have Skills

• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Health Care Provider and Legal

• Industries

  Medical Equipment Manufacturing, Biotechnology Research, and Hospitals and Health Care

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