RA Manager- Medical Device
Prestigious multinational company with promising product in the pipeline
Leadership position responsible for people management
About Our Client
Our client is one of the most prestigious medical device company operating in more than 100 countries, providing a broad portfolio of surgery products.
Now, they are looking for a Regulatory Affairs Manager with people management experience and wiliness to join and bring the company forward.
- Manage all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned regulatory submissions.
- Ensure adherence to internal standards and processes, as well as health authority requirements.
- Provide expert advises and guidance to project teams regarding the TFDA submissions.
- Provide regulatory input and advice on the creation, implementation, and revision of SOPs.
- Keep abreast of current regulatory environment in Taiwan and other applicable markets.
- Perform other regulatory affairs functions as necessary.
The Successful Applicant
- Bachelor or above degree in scientific discipline.
- 7+ years of experience in medical device, biotech, or other relevant industry.
- 5+ years of increasing regulatory affairs experience.
- Experience in TFDA Class II and Class III is a MUST.
- Solid people management experience with proven track record.
What's on Offer
- Great working environment
- Excellent Career advancement