Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

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We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Senior Specialist, Regulatory Affairs plays a key role in ensuring Becton, Dickinson and Company's medical devices and Advanced Patient Monitoring Business Unit. This position involves supporting regulatory submissions, maintaining product compliance, and providing regulatory guidance to cross-functional teams for our China regional market. The Bilingual Mandarin Chinese and English Senior Specialist, Regulatory Affairs plays a critical role in ensuring regulatory compliance for BD’s Advanced Patient Monitoring (APM) product portfolio.

This position is responsible for supporting regulatory submissions, maintaining product compliance, and providing strategic regulatory guidance to cross-functional teams across the China, Taiwan, and Hong Kong markets. This remote based position must be within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones to ensure effective collaboration with cross-functional teams.

• Support regional Regulatory team to provide design dossiers, technical writings for NMPA submissions.
• Interpret and apply applicable regulations, standards, and guidance documents (e.g., GB/YY standards, NMPA guidance documents) to product development, manufacturing, and post-market activities.
• Serve as a regulatory subject matter expert for product development teams, providing guidance on regulatory strategies, design controls, risk management, and labeling requirements.
• Support post-market surveillance activities, including adverse event reporting, field actions, and regulatory responses to health authority inquiries.
• Review and approve labeling for regional expansion.
• Participate in internal and external audits.
• Collaborate effectively with cross-functional teams including R&D, Quality, Marketing, and manufacturing sites 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 electronic or vascular products for the China, Hong Kong, and Taiwan regulatory agencies.

• Strong understanding of China, Hong Kong and Taiwan medical device regulations.

• Demonstrated experience in preparing and submitting APAC regulatory filings, supporting type testing.
• Sound understanding of design control processes.
• Proven experience collaborating cross-functionally with R&D, Quality, and Manufacturing teams.
• Demonstrated ability to lead and manage complex regulatory projects across multiple departments and stakeholders, ensuring compliance with global standards, alignment of objectives, timely execution, and successful outcomes that support product approvals and submissions.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory requirements clearly and concisely.
• Proven ability to work independently and as part of a team in a fast-paced, dynamic environment.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook and Teams).
• Ability to travel occasionally as required (less than 10%).

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

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