**About the Role:**
As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. You will guide product teams through compliant design and commercialization and represent the company in high-stakes regulatory interactions. This role is critical as we scale our medical device offerings and strengthen our global regulatory posture.

**Responsibilities:**

**Regulatory**

+ Support development of global regulatory requirements for new and existing SaMD products (e.g. FDA, EU MDR, UKCA, TGA, Health Canada, MDSAP jurisdictions)
+ Serve as primary author and owner of major submissions, including 510(k), De Novo requests, CE Technical Documentation, UKCA dossiers, and global regulatory filings
+ Advise Product leadership on regulatory pathways, classification, predicate selection, clinical evidence needs, and market expansion opportun...