Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Employer Industry

Medical Technology

• Salary up to $133,000
• Opportunity for career advancement and growth within the organization
• Remote work flexibility within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
• Collaborative and innovative work environment focused on creativity and problem-solving
• Chance to make a positive impact in the healthcare industry through regulatory compliance

• Support regional Regulatory team with design dossiers and technical writings for NMPA submissions
• Interpret and apply regulations and standards to product development and post‑market activities
• Serve as a regulatory subject matter expert for product development teams
• Support post‑market surveillance activities, including adverse event reporting and regulatory responses
• Collaborate effectively with cross‑functional teams to achieve regulatory objectives

• Bachelor's degree in a scientific or technical discipline such as Biomedical Engineering, Chemistry, Biology, Pharmacy, or Regulatory Affairs
• Must be fluent in Mandarin Chinese and English (read, write, and speak)
• Minimum of 5 years of experience in Regulatory Affairs within the medical device industry
• Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
• Proven ability to manage complex regulatory projects across multiple departments

• Advanced degree (Master's or Ph.D.) preferred but not required

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