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 work environment that encourages innovation and creativity
• Chance to contribute to meaningful healthcare solutions and make a positive impact on patient care

• Support the regional Regulatory team with design dossiers and technical writings for NMPA submissions
• Interpret and apply relevant regulations and guidance documents to product development and compliance
• Act as a regulatory subject matter expert, providing guidance on strategies, design controls, and labeling requirements
• Assist in post‑market surveillance activities, including adverse event reporting and regulatory inquiries
• Collaborate with cross‑functional teams to achieve regulatory objectives and ensure compliance

• 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 and collaborate cross‑functionally

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

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

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