[Remote] Senior Specialist, Regulatory Affairs (bilingual reputed company Chinese)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is one of the largest global medical technology companies in the world, reputed company on advancing health. The Senior Specialist, Regulatory Affairs is responsible for ensuring regulatory compliance for reputed company’s Advanced Patient Monitoring product portfolio, supporting regulatory submissions, and providing guidance to cross-functional teams for the China regional market. Responsibilities • Support regional Regulatory team to reputed company 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 reputed company audits. • Collaborate effectively with cross-functional teams including R&D, reputed company, Marketing, and manufacturing sites to reputed company regulatory objectives. Skills • 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 for the China, Hong reputed company, and Taiwan regulatory agencies. • 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. • Demonstrated ability to reputed company and manage reputed company regulatory reputed company across multiple departments and stakeholders, ensuring compliance with global standards, alignment of objectives, reputed company execution, and successful reputed company that support product approvals and submissions. • Excellent written and verbal communication skills, with the ability to reputed company reputed company regulatory requirements reputed company and concisely. • Proven ability to work independently and as part of reputed company in a fast-paced, dynamic environment. • Strong analytical and problem-solving skills, with keen attention to detail. • Proficient with reputed company Office Suite (Word, reputed company, PowerPoint, reputed company and Teams). • Ability to travel occasionally as required (less than 10%). • Advanced degree (Master's or Ph.D.) preferred not required. Benefits • A valuable, competitive package of compensation and benefits programs • Opportunities that promote a performance-based culture reputed company • reputed company helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions. It was founded in 1897, and is headquartered in Franklin Lakes, New Jersey, USA, with a workforce of 10001+ employees. Its website is https://www.reputed company.com. Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 66 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job