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
• Work remotely while collaborating with cross‑functional teams
• Supportive and collaborative work environment
• Chance to make a positive impact on product compliance and patient safety
• Commitment to employee well‑being and development with competitive compensation and benefits

• Support the regional Regulatory team with 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, providing guidance on regulatory strategies
• Support 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
• 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

#Medical Technology #Regulatory Affairs #Career Opportunity #Remote Work #Competitive Pay

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