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
• Remote work position with flexibility within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
• Collaborative and supportive work environment that values employee contributions
• Chance to work on transformative solutions in healthcare, making a positive impact on patient monitoring

• Support the regional regulatory team in preparing design dossiers and technical writings for NMPA submissions
• Interpret and apply applicable regulations, standards, and guidance documents to product development and post-market activities
• Serve as a regulatory subject matter expert, providing guidance on regulatory strategies and compliance
• Support post-market surveillance activities, including adverse event reporting and regulatory responses
• Collaborate with cross-functional teams including R&D, Quality, Marketing, and manufacturing 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, specifically 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

#Medical Technology #Regulatory Affairs #Career Opportunity #Remote Work #Healthcare Innovation

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