Senior Specialist, Regulatory Affairs, Bilingual Mandarin Chinese

Job 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 Apply tot his job