Sr. RA Specialist
Hybrid · Taipei, Taiwan, Taiwan
Job Summary
Senior Regulatory Affairs Specialist responsible for product registration strategies, approvals, renewals, and maintenance of licenses for medical devices in Taiwan. Key duties include planning and executing registration submissions, ensuring compliance with local regulations, labeling validation, regulatory intelligence, QMS alignment, audits, CAPA follow-up, and cross-functional collaboration (clinical trials, market access). Requires extensive RA experience in medical devices, knowledge of Taiwan regulations and ISO13485, and strong communication skills in Chinese and English.
Required Qualifications
- Knowledge of Taiwan medical device act & regulations, ISO13485
- Preferred >9 years of relevant RA experience in the medical device industry
- Proven ability to review and translate technical documentation into effective regulatory submissions
- Bachelor’s degree in science, engineering, medical technology, life sciences or similar is required
- Completed at least 20 hours of education and training in the past five years on topics related to medical devices regulations, quality management systems, and regulatory submissions
- Excellent written and verbal communication skills in Chinese and English
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.