DeepQ - Regulatory Affairs Specialist - J01549

Join the creative thinkers at HTC Healthcare. At this innovation center we are looking for brilliant talents to join our team. We help create the exciting future of AI-powered services. Our work is creative, stimulating, and fun. Our atmosphere is open, friendly, and inspiring.

DeepQ:deepq.com

• To manage the government approval activities such as manufacturing site registration and product registration to facilitate and ensure smooth and timely introduction of new products according to business needs.

• To ensure the organizational operation is in compliance with corporate policies and local regulations for Pharmaceutical Affairs Act and ISO13485 related requirements.

• Monitor and update new and changed regulations as well as provide impact analysis to Regulatory Affairs Manager. Monitor and make sure the company activities are compliant or fulfil the most current regulations/ requirements.

• Provide monthly submission and approval status report of assigned projects and highlight issues and impacts to Regulatory Affairs Manager.

Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry. Master degree preferred

-Over 2 years' related working experience in medical regulatory affairs, keep good relationship with authorities and officials

-Willing to work under pressure, self-starting and self-inspiring

-Familiar with medical device regulations