Regulatory Affairs Lead – SaMD & Global Submissions

Median Technologies seeks a Regulatory Affairs Manager to lead regulatory strategy for our SaMD portfolio and ensure ongoing worldwide compliance. You will collaborate with Clinical, Quality, R&D, Product and Marketing to drive submissions and maintain lifecycle regulatory control.

The role requires MDR/CE expertise, US FDA experience and the ability to act as Deputy PRRC. The candidate will manage regulatory databases and stay ahead of global regulatory changes affecting the portfolio.