Regulatory Affairs Specialist (Hybrid)

Job Description

By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground‑breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart‑related complications.

Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – a product with strong, unique, and customer‑valued differentiators versus other solutions on the market.

We have obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life‑changing technology to patients.

As a Regulatory Affairs Specialist, Change Control, you will be responsible for assessing product, process, design, manufacturing, label...