Roche is seeking a Regulatory Affairs Project Manager (m/f/d) to lead international regulatory submissions for medical devices and in vitro diagnostics within the Global Regulatory Affairs organization. The focus areas include cardiology, endocrinology and fertility, and the portfolio of Elecsys and Point of Care solutions. The role involves providing strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams to create an efficient, compliant environment. You will manage product registrations in Europe, the United States, and China and support worldwide registrations; prepare and submit premarket submissions to FDA or Notified Bodies, acting as the primary interface with health authorities; and maintain up-to-date technical documentation. You will collaborate with colleagues in Germany, Switzerland, and the US, and with global Regulatory Affairs teams in China and Japan to enable timely approvals. Qualifications include a Bachelor’s or Master’s degree in Life Science, Data Science or related field; at least five years of experience in Regulatory, R&D, Quality, Operations, or Clinical; technical knowledge of medical devices or IVDs; knowledge of international development and registration regulations (EU, US, China); and excellent English. Additional languages are advantageous. You should be comfortable working in a multicultural, matrix-structured environment, able to shift priorities, and able to take informed decisions. Please apply with a current CV and relevant certificates; other documents, such as a cover letter, are optio

Roche is seeking a Regulatory Affairs Project Manager (m/f/d) to lead international regulatory submissions for medical devices and in vitro diagnostics within the Global Regulatory Affairs organization. The focus areas include cardiology, endocrinology and fertility, and the portfolio of Elecsys and Point of Care solutions. The role involves providing strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams to create an efficient, compliant environment. You will manage product registrations in Europe, the United States, and China and support worldwide registrations; prepare and submit premarket submissions to FDA or Notified Bodies, acting as the primary interface with health authorities; and maintain up-to-date technical documentation. You will collaborate with colleagues in Germany, Switzerland, and the US, and with global Regulatory Affairs teams in China and Japan to enable timely approvals. Qualifications include a Bachelor’s or Master’s degree in Life Science, Data Science or related field; at least five years of experience in Regulatory, R&D, Quality, Operations, or Clinical; technical knowledge of medical devices or IVDs; knowledge of international development and registration regulations (EU, US, China); and excellent English. Additional languages are advantageous. You should be comfortable working in a multicultural, matrix-structured environment, able to shift priorities, and able to take informed decisions. Please apply with a current CV and relevant certificates; other documents, such as a cover letter, are optio