Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Employer Industry: Medical Technology

• Salary up to $133,000 annually
• Opportunity for career advancement and growth within the organization
• Supportive and collaborative work environment
• Chance to make a positive impact in the healthcare industry
• Flexibility of remote work within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
• Commitment to employee well-being and development with competitive compensation and benefits

• Support the regional Regulatory team by providing design dossiers and technical writings for NMPA submissions
• Interpret and apply applicable regulations, standards, and guidance documents for product development and compliance
• Serve as a regulatory subject matter expert, guiding product development teams on regulatory strategies and requirements
• Support post-market surveillance activities, including adverse event reporting and regulatory responses
• Collaborate with cross-functional teams, including R&D, Quality, and Marketing 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, particularly for Class II and/or Class III products
• Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
• Proven ability to lead and manage complex regulatory projects across multiple departments

• Advanced degree (Master's or Ph.D.) in a relevant field

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