Senior Specialist, Regulatory Affairs, Bilingual Mandarin Chinese

Yesterday

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

⛰️ Colorado – Remote

Although this job is listed in Colorado, this company may be open to hiring remote in other states.

+2 more states

🏄 California – Remote ⛰️ Colorado – Remote 🌲 Oregon – Remote 🗿 South Dakota – Remote

💵 $80.6k - $133k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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BD

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Healthcare Insurance • Pharmaceuticals • Science

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

10,000+ employees

Founded 1897

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

💰 $24M Grant on 2020-07

📋 Description

• Support regional Regulatory team to provide design dossiers, technical writings for NMPA submissions. • Interpret and apply applicable regulations, standards, and 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.

🎯 Requirements

• 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. • 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. • Excellent written and verbal communication skills, with the ability to articulate complex regulatory requirements clearly and concisely.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible working hours • Paid time off • Remote work options • Professional development opportunities