Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Job Overview

Senior Specialist, Regulatory Affairs (Bilingual Mandarin Chinese and English) for BD’s Advanced Patient Monitoring (APM) product portfolio in China, Taiwan, and Hong Kong. The position is remote and must be located within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones to collaborate effectively with cross‑functional teams.

• Support regional regulatory team to provide design dossiers and technical writing 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.
• Fluency 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 and supporting type testing.
• Sound understanding of design control processes.
• Proven experience collaborating cross‑functionally with R&D, Quality, and Manufacturing teams.
• 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.
• 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.
• Proficiency 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 but not required.

Primary

Work Location:

USA CA - Irvine Laguna Canyon.
Salary Range: $80,600.00 – $ USD Annual.

Becton, Dickinson & Company is an Equal Opportunity Employer and commits to not discriminating on the basis of any legally protected characteristic. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

COVID‑19 vaccination or testing requirements are contingent upon local regulations and the company’s policy. Requests for accommodation are considered in accordance with applicable law.