Regulatory Affair

Job opening: Regulatory Affair
Job Description 1.    Manage the ISO 13485 quality system, including routine maintenance and outsourcing audits.
2.    Leading GMP audit practice and writing related audit proposal.
3.    FDA, TFDA, CE, NMPA listing document preparation and maintenance.
4.    Patent and trademark project maintenance.
5.    Attend the relevant regulations briefing, coordinate with the competent authority and relevant units, update relevant regulations and standards, and ensure that the company's products comply with the regulations.
6.    Project planning and progress management tracking.
7.    Complete tasks assigned by supervisor.
 

Basic Condition

 Gender: □ Male □ Female ■ Not specified
Age: □ Below 35 years old ■ Not specified
Education: □ High school □ Junior college ■ Bachelor ■ Master ■ PhD
Department: □ Limited to_____ related departments ■ Not specified
Marriage: □ Married □ Unmarried ■ Not Specified
Military Service Status: □ Discharged □ Not served ■ Not specified
Driver's License: □ Motorcycle □ Car ■ Not Specified
 

Language Skills

 English: □ Not Specified □ With reading skill ■ With normal reading and writing skill □ With fluent listening, speaking, reading, and writing skill
Japanese: □ Not Specified □ With reading skill □ With normal reading and writing skill □ With fluent listening, speaking, reading, and writing skill
_______: □ Not Specified □ With reading skill □ With normal reading and writing skill □ With fluent listening, speaking, reading, and writing skill
_______: □ Not Specified □ With reading skill □ With normal reading and writing skill □ With fluent listening, speaking, reading, and writing skill
 
 

Computer Skills

WORD: □ Not specified ■ Capable □ Proficient

EXCEL: □ Not specified ■ Capable □ Proficient

POWER POINT: □ Not specified ■ Capable □ Proficient

ACESS: □ Not specified □ Capable □ Proficient

        : □ Not specified □ Capable □ Proficient

        : □ Not specified □ Capable □ Proficient

Chinese Typing Speed:       word/min

English Typing Speed:       word/min
 

Other Specialty and Skills

 1.    Familiar with medical device inspection and registration regulations (TFDA, FDA, CE, NMPA) or have more than two years of medical device inspection and registration work experience.
2.    Those with biomedicine, medical engineering, medical equipment, medical electronics related experience is preferred.
3.    Excellent in both Chinese and English.
4.    Familiar with Quality Management System.
5.    Experience in project management.
6.    Ability to work independently.
Work Experience At least 2 years of working experience in the related field
Salary negotiable
Holiday System Five-day work week
Date of Availability Onboard after admission
Application Method

Please email resume to our HR, Mrs. Guo admin@bioware.com.tw

Tel 02-8691-6959 Ext. 15