Senior Specialist, Regulatory Affairs; bilingual Mandarin Chinese
Job Description & How to Apply Below
Employer Industry: Medical Technology
Why consider this job opportunity- Salary up to $133,000 annually
- Opportunity for career advancement and growth within the organization
- Flexible remote work option within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
- Supportive and collaborative work environment across cross‑functional teams
- Chance to contribute to transformative solutions in healthcare
- Support regional regulatory team by providing design dossiers and technical writings for NMPA submissions
- Interpret and apply applicable regulations and standards to product development and post‑market activities
- Serve as a regulatory subject matter expert for product development teams
- Support post‑market surveillance activities, including adverse event reporting and regulatory responses
- Collaborate effectively with cross‑functional teams including R&D, Quality, Marketing, and manufacturing sites
- 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
- Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
- Proven ability to lead and manage complex regulatory projects across multiple departments
- Advanced degree (Master's or Ph.D.) preferred but not required
#Medical Technology #Regulatory Affairs #Career Opportunity #Remote Work #Healthcare Innovation
"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position.
Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×