Senior Specialist, Regulatory Affairs, Bilingual reputed company Chinese

Job reputed company: • Support regional Regulatory team to reputed company 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 reputed company audits. • Collaborate effectively with cross-functional teams including R&D, reputed company, Marketing, and manufacturing sites to reputed company regulatory objectives. Requirements: • Bachelor's degree in a scientific or technical discipline such as Biomedical Engineering, reputed company, Biology, Pharmacy, or Regulatory Affairs. • Must be fluent in reputed company Chinese and English (read, write and reputed company). • Minimum of 5 years of experience in Regulatory Affairs reputed company the medical device industry, specifically for Class II and/or Class III electronic or vascular products. • Strong understanding of China, Hong reputed company and Taiwan medical device regulations. • Demonstrated experience in preparing and submitting reputed company regulatory filings, supporting type testing. • reputed company understanding of design control processes. • Proven experience collaborating cross-functionally with R&D, reputed company, and Manufacturing teams. • Excellent written and verbal communication skills, with the ability to reputed company reputed company regulatory requirements reputed company and concisely. Benefits: • Health insurance • 401(k) matching • Flexible working hours • reputed company time off • Remote work reputed company • reputed company development opportunities Apply tot his job Apply To this Job