Global Biotechnology company focusing on innovative precision based cancer therapies
Communicate with overseas manufacturers to improve / develop the medical device components.
Build strong relationship with external partners
【WHY YOU SHOULD APPLY】
You will be the pioneering person for this role in the company
Career development support (training and promotions)
Start up environment
Working with a diverse and motivated team with excellent work culture
5+ years Knowledge of relevant Medical Device industry.
Experience of managing Medical Device class Ⅱ or Ⅲ
Knowledge of through the product planning, specification determination, design, and evaluation.
Experience in the manufacture for medical devices is plus
Understanding of relevant regulations and guidelines, e.g. ISO13485, ISO14971, IEC60601-1 and IEC60601-1-2.
Knowledge of QMS and / or ISO 13485, or sufficient knowledge of quality certification
Very good communication and problem solution skill among cross-functional team.
Ability to communicate reading, writing and speaking.
Bachelor's Degree in Engineering or related discipline
Strong Communication skill with external parties.