Regulatory Affairs Specialist
Job Description:
- Conduct product registration, license applications/changes, and document writing for pharmaceuticals, medical devices, cosmetics, and food products. Compile product information according to relevant regulatory requirements and procedures, ensuring compliance with both domestic and international authority.
- Application for medical device Quality Management System (QMS/QSD); PIC/GMP applications for pharmaceutical factories.
- Stay updated on domestic and international pharmaceutical and medical device regulations, ensuring compliance with government requirements and regulations.
- Review and compile relevant domestic and international literature.
- Handle overseas product registration, GMP applications, and matters related to ISO 13485/ISO 14971.
- Provide regulatory consulting services to clients regarding product registration strategies.
Required Qualifications and Experience:
- Degree in pharmacy, public health, or biomedical field or equivalent;
- Excellent communication skills;
- Excellent document writing and editing abilities;
- In pharmaceutical or medical device companies work experiences a plus.
If you are interested, you are welcome to submit your resume on the 104 website:
https://vip.104.com.tw/job/jobmaster?jobno=13221173
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