Regulatory Affairs Specialist

Join an international division and work alongside some of the most talented engineers and technicians from all over the world.

Responsibilities

• Support and manage regulatory activities related to the registration and approval of medical devices in China.
• Navigate and coordinate NMPA submission and approval processes.
• Ensure compliance with Chinese regulatory requirements and applicable standards.
• Collaborate with cross‑functional international teams, including Quality, Clinical, and Product Development.
• Provide regulatory guidance and risk assessment throughout the project lifecycle.

Requirements

• Proven experience in Regulatory Affairs within the medical device industry.
• Hands‑on experience with NMPA regulations, submissions, and approval processes.
• Strong understanding of the Chinese regulatory landscape and experience with Class II and/or...