Senior Regulatory Affairs Specialist

Job description

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 opportunities - Support regulatory interactions with FDA, Notified Bodies, and other competent authorities Standards & Compliance: - Ensure compliance with global medical device regulations and software standards (e.g. 21 CFR Part 820/11, EU MDR 2017/745,...