BD
Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
BD, Oklahoma City, Oklahoma, United States
Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
Join to apply for the
Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
role at
BD .
BD is one of the largest global medical technology companies in the world. Our purpose is to advance the world of health™. We work across design, engineering, manufacturing and marketing to create transformative solutions that turn dreams into possibilities.
Job Summary The Senior Specialist, Regulatory Affairs plays a key role in ensuring BD’s Advanced Patient Monitoring (APM) product portfolio meets regulatory requirements in China, Taiwan, and Hong Kong. This remote‑based position (PST or MST) supports regulatory submissions, maintains product compliance, and provides strategic regulatory guidance to cross‑functional teams.
Job Responsibilities
Support the regional regulatory team with design dossiers and technical writings for NMPA submissions.
Interpret and apply applicable regulations, standards, and guidance documents (e.g., GB/YY standards, NMPA guidance) 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 with R&D, Quality, Marketing, and manufacturing sites to achieve regulatory objectives.
Education and Experience Required
Bachelor’s degree in a scientific or technical discipline such as Biomedical Engineering, Chemistry, Biology, Pharmacy, or Regulatory Affairs.
Fluent in Mandarin Chinese and English (reading, writing, speaking).
Minimum of 5 years of regulatory affairs experience in the medical device industry, specifically for Class II and/or Class III electronic or vascular products for China, Hong Kong, and Taiwan regulatory agencies.
Knowledge and Skills Required
Strong understanding of China, Hong Kong, and Taiwan medical device regulations.
Experience 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 stakeholders, ensuring compliance with global standards and timely execution.
Excellent written and verbal communication skills.
Independent and collaborative work style 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, Teams).
Occasional travel (less than 10%).
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) preferred.
At BD, we prioritize on‑site collaboration but also allow flexibility. Remote or field‑based positions may have different workplace arrangements. For certain roles, vaccination against COVID‑19 is required; accommodation requests are considered under applicable law.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to a wide range of protected characteristics, including but not limited to race, color, religion, age, sex, creed, nationality, citizenship, marital status, familial status, sexual orientation, gender identity, genetics, disability, veteran status, and other legally protected characteristics.
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Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
role at
BD .
BD is one of the largest global medical technology companies in the world. Our purpose is to advance the world of health™. We work across design, engineering, manufacturing and marketing to create transformative solutions that turn dreams into possibilities.
Job Summary The Senior Specialist, Regulatory Affairs plays a key role in ensuring BD’s Advanced Patient Monitoring (APM) product portfolio meets regulatory requirements in China, Taiwan, and Hong Kong. This remote‑based position (PST or MST) supports regulatory submissions, maintains product compliance, and provides strategic regulatory guidance to cross‑functional teams.
Job Responsibilities
Support the regional regulatory team with design dossiers and technical writings for NMPA submissions.
Interpret and apply applicable regulations, standards, and guidance documents (e.g., GB/YY standards, NMPA guidance) 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 with R&D, Quality, Marketing, and manufacturing sites to achieve regulatory objectives.
Education and Experience Required
Bachelor’s degree in a scientific or technical discipline such as Biomedical Engineering, Chemistry, Biology, Pharmacy, or Regulatory Affairs.
Fluent in Mandarin Chinese and English (reading, writing, speaking).
Minimum of 5 years of regulatory affairs experience in the medical device industry, specifically for Class II and/or Class III electronic or vascular products for China, Hong Kong, and Taiwan regulatory agencies.
Knowledge and Skills Required
Strong understanding of China, Hong Kong, and Taiwan medical device regulations.
Experience 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 stakeholders, ensuring compliance with global standards and timely execution.
Excellent written and verbal communication skills.
Independent and collaborative work style 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, Teams).
Occasional travel (less than 10%).
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) preferred.
At BD, we prioritize on‑site collaboration but also allow flexibility. Remote or field‑based positions may have different workplace arrangements. For certain roles, vaccination against COVID‑19 is required; accommodation requests are considered under applicable law.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to a wide range of protected characteristics, including but not limited to race, color, religion, age, sex, creed, nationality, citizenship, marital status, familial status, sexual orientation, gender identity, genetics, disability, veteran status, and other legally protected characteristics.
#J-18808-Ljbffr