Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Position:Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)Join to apply for theSenior Specialist, Regulatory Affairs (bilingual Mandarin Chinese) role at BD (Tissuemed Ltd). BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.Job SummaryTheSenior Specialist, Regulatory Affairs plays a key role in ensuring Becton, Dickinson and Company's medical devices andAdvanced 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 EnglishSenior Specialist, Regulatory Affairs plays a critical role in ensuring regulatory compliance for BD’sAdvanced 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. Job Responsibilities• 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. Educations And Experience Required• 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.Knowledge And Skills Required• 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 bolthires Office Suite (Word, Excel, PowerPoint, Outlook and Teams). • Ability to travel occasionally as required (less than 10%). Preferred Qualifications• Advanced degree (Master's or Ph.D.) preferred not required.Remote / Work ArrangementFor most roles, we require a minimum of 4 days of in‑office presence per week to maintain our… Apply tot his job