Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Why consider this job opportunity

• Salary up to $133,000
• Opportunity for career advancement and growth within the organization
• Supportive and collaborative work environment
• Chance to make a positive impact in the medical technology field
• Flexible remote work arrangement within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones

• Support the regional Regulatory team by providing design dossiers and technical writings for regulatory submissions
• Interpret and apply applicable regulations and standards to product development and post‑market activities
• Serve as a regulatory subject matter expert for product development teams, offering 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, 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 for Class II and/or Class III products
• Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
• Proven experience collaborating cross‑functionally with R&D, Quality, and Manufacturing teams

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

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