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Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
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Job Description
- Req#: R-532635
Employer Industry: Medical Technology
Why consider this job opportunity:
- Salary up to $133,000
- Opportunity for career advancement and growth within the organization
- Work remotely within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
- Supportive and collaborative work environment
- Chance to make a positive impact on regulatory compliance in the healthcare industry
What to Expect (Job Responsibilities):
- Support regional Regulatory team with design dossiers and technical writings for NMPA submissions
- Interpret and apply applicable regulations and guidance documents to product development and post-market activities
- Serve as a regulatory subject matter expert for product development teams, providing guidance on regulatory strategies and requirements
- Support post-market surveillance activities, including adverse event reporting and regulatory responses
- Collaborate effectively with cross-functional teams to achieve regulatory objectives
What is Required (Qualifications):
- 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, specifically for Class II and/or Class III products
- Strong understanding of China, Hong Kong, and Taiwan medical device regulations
- Proven ability to lead and manage complex regulatory projects across multiple departments
How to Stand Out (Preferred Qualifications):
- Advanced degree (Master's or Ph.D.) preferred not required
- Demonstrated experience in preparing and submitting APAC regulatory filings
- Strong analytical and problem-solving skills with keen attention to detail
#MedicalTechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #RemoteWork
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