Regulatory Affairs Manager | Regulatory Affairs Manager (m/w/d)

Job Summary

As a Regulatory Affairs Manager at Roche, you will serve as a vital link between product development and clinical trials, ensuring innovative diagnostic solutions reach global markets safely. On a day-to-day basis, you will navigate complex regulatory landscapes, specifically focusing on IVDR and CLIA regulations, while developing strategic global registration plans for markets across the USA, Europe, and APAC. You will be responsible for preparing regulatory dossiers, managing relationships with external stakeholders and authorities, and representing the company during audits. This role is ideal for a professional with a background in Life Sciences or Data Science and significant experience in the IVD or medical technology sectors. Joining Roche offers the unique opportunity to work within a dynamic, international team that values personal expression and authenticity, operating under the VACC leadership principles to drive continuous improvement in global healthcare access.