Senior Specialist, Regulatory Affairs; bilingual reputed company Chinese

Position: Senior Specialist, Regulatory Affairs (bilingual reputed company Chinese) Senior Specialist, Regulatory Affairs (bilingual reputed company Chinese) Join to apply for the Senior Specialist, Regulatory Affairs (bilingual reputed company 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 reputed company transformative solutions that turn dreams into reputed company. Job reputed company 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 reputed company 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 reputed company reputed company Time (PST) or Mountain reputed company Time (MST) zones to ensure effective collaboration with cross‑functional teams. Job 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.

Educations And Experience Required

• 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.

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.
• 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, 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