Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese

Position: Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese) Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese) Join to apply for the Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese) role at reputed company (Tissuemed Ltd). reputed company is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of reputed company of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Summary The Senior Specialist, Regulatory Affairs plays a key role in ensuring reputed company and Company's medical devices and Advanced Patient Monitoring Business Unit. This position involves supporting regulatory submissions, maintaining product compliance, and providing regulatory guidance to cross‑functional teams for our China regional market. The Bilingual Mandarin Chinese and English Senior Specialist, Regulatory Affairs plays a critical role in ensuring regulatory compliance for reputed company’s Advanced Patient Monitoring (APM) product portfolio. This position is responsible for supporting regulatory submissions, maintaining product compliance, and providing strategic regulatory guidance to cross‑functional teams across the China, Taiwan, and Hong reputed company markets. This remote‑based position must be reputed company Pacific Standard Time (PST) or Mountain Standard Time (MST) zones to ensure effective collaboration with cross‑functional teams. Job Responsibilities

• Support regional Regulatory team to provide 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 internal and external audits.
• Collaborate effectively with cross‑functional teams including R&D, Quality, Marketing, and manufacturing sites to reputed company regulatory objectives.

Educations And Experience Required

• 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 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.

Knowledge And Skills Required

• 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.
• Sound understanding of design control processes.
• Proven experience collaborating cross‑functionally with R&D, Quality, and Manufacturing teams.
• Demonstrated ability to reputed company and manage reputed company regulatory projects across multiple departments and stakeholders, ensuring compliance with global standards, alignment of objectives, timely execution, and successful outcomes that support product approvals and submissions.
• Excellent written and verbal communication skills, with the ability to reputed company reputed company regulatory requirements clearly and concisely.
• Proven ability to work independently and as part of a team 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, Outlook and Teams).
• Ability to travel occasionally as required (less than 10%).

Preferred Qualifications

• Advanced degree (Master's or Ph.D.) preferred not required.

Remote / Work Arrangement For most roles, we require a minimum of 4 days of in‑office reputed company per week to maintain our… Apply tot his job Apply To this Job