法規工程師

At Point Robotic, we design and build advanced robotic systems for minimally invasive spine surgery (MISS). Our mission is simple: make healthcare better for people. If you're passionate about medical tech and robotics, come build the future with us - Let's Point to a Better Life! 【Key Responsibilities】 ■ Prepare technical documents for competent authorities. Documents include software validation, electronic safety, performance evaluation, UEF, and reprocessing verification, etc. ■ Participate in product development processes and provide support for regulatory requirements, including verification and validation reports, and risk assessment, etc. ■ Manage internal communication and support RD members in establishing required technical documents. ■ Assist in submission activities for global pre-market submission and post-market maintenance. #ISO13485 #510K #MDR