PM and Quality Assurance/Regulatory Affairs

Taipei, Taiwan, Full-Time

The Team

We are looking for young talent with strong motivation to learn and grow with the company. This role presents an exceptional opportunity to collaborate with top professionals worldwide, engage with esteemed entities to revolutionize clinical trials.

• Develop strategies and engage with regulatory authorities and industry/academic partners to establish new standards for the adoption of Vysioneer's novel AI technology in drug development.
• Conduct market research and literature review to support business development.
• Maintain Quality Management System – develop documentation in adherence to QMS SOPs and standards; organize quality related activities including internal and external audits.
• Prepare and submit regulatory submissions to regulatory authorities for new product registration and ensure product compliance with relevant laws, regulations, and guidelines.
• Work with the software product team to establish technical and product documentation.
• Support ad hoc and admin tasks as they arise.

Requirements

• No prior relevant experience is required. We are seeking young talent and will provide opportunities to cultivate and develop you into an expert in Quality Assurance and Regulatory Affairs in the field of software as a medical device (SaMD) and AI for clinical trials.
• Team player, strong ownership, can-do mentality, and the ability to meet deadlines.
• Motivated, proactive and willing to learn within a very collaborative and fast-paced environment.
• Excellent written and verbal communication skills in English. (Most of your external counterparts at work are English-speaking and you will be responsible for leading meetings with the FDA.)

Please apply through submitting your resume/CV to info@vysioneer.com