Sr RA Design Quality Engineer

To reinforce our Regulatory Affairs and Quality Assurance department, and to continue our business expansion with new market introduction, especially the USA, we are looking to fill the position of:

Senior Regulatory Affairs Design Quality Engineer

Reporting to the Regulatory Affairs Manager, you are responsible for the following activities, in accordance with applicable regulatory requirements (EU, US, AU, UK, CH, etc) and leveraging your background and demonstrated experience in medical device manufacturing:

• Regulatory Interactions: You are the primary point of contact for interactions with Competent Authorities (ANSM, FDA, TGA, MHRA, Swissmedic, …) and our European Notified Body. You prepare, argue, and defend Symbios technical and regulatory positions in the context of pre- and post-market submissions (Tech. Doc., 510k, changes notification), audits, inspections, and other queries, demonstrating the ability to engage constructiv...