Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Employer Industry: Medical Technology

• Salary up to $133,000 annually
• Opportunity for career advancement and growth within a leading global medical technology company
• Flexible remote work arrangement within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
• Supportive and collaborative work environment that values contributions and encourages authenticity
• Chance to make a significant impact in the healthcare industry through innovative regulatory solutions

• Support the regional regulatory team by providing design dossiers and technical writings for regulatory submissions
• Interpret and apply applicable regulations, standards, and guidance documents to product development and post-market activities
• Serve as a regulatory subject matter expert, offering guidance on regulatory strategies, design controls, and labeling requirements
• Assist with 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 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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