The Global Regulatory Medical Device, Combination Products, & CMC Lead develops the global regulatory strategy for assigned Sobi assets in development and assess the filing strategy of post-approval changes. This role acts as Sobi’s lead for Medical Devices and Combination Products and is responsible for Sobi’s activities in medical device development, registration, and maintenance, on a global basis. The role holder is expected to demonstrate proven experience and leadership in drug/device combination products and in medical devices (including companion diagnostics) development and approval. The role holder will work closely with Global Manufacturing Sciences subject matter experts, Quality representatives, and cross-functional stakeholders in Global Regulatory Affairs. Please note this role is remote but candidate will have occasional travel/meetings in the Waltham MA/Stockholm Sweden offices.