BD
Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
BD, Denver, Colorado, United States
Why consider this job opportunity
Salary up to $133,000
Opportunity for career advancement and growth within the organization
Supportive and collaborative work environment
Chance to make a positive impact in the medical technology field
Flexible remote work arrangement within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
Job Responsibilities
Support the regional Regulatory team by providing design dossiers and technical writings for regulatory 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, offering guidance on regulatory strategies and compliance
Support post‑market surveillance activities, including adverse event reporting and regulatory responses
Collaborate with cross‑functional teams, including R&D, Quality, and Marketing, to achieve regulatory objectives
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 for Class II and/or Class III products
Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
Proven experience collaborating cross‑functionally with R&D, Quality, and Manufacturing teams
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) preferred but not required
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.
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Salary up to $133,000
Opportunity for career advancement and growth within the organization
Supportive and collaborative work environment
Chance to make a positive impact in the medical technology field
Flexible remote work arrangement within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
Job Responsibilities
Support the regional Regulatory team by providing design dossiers and technical writings for regulatory 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, offering guidance on regulatory strategies and compliance
Support post‑market surveillance activities, including adverse event reporting and regulatory responses
Collaborate with cross‑functional teams, including R&D, Quality, and Marketing, to achieve regulatory objectives
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 for Class II and/or Class III products
Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
Proven experience collaborating cross‑functionally with R&D, Quality, and Manufacturing teams
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) preferred but not required
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.
#J-18808-Ljbffr