Experience should include HF/UE activities conducted in accordance with IEC 62366-1 and FDA HF/UE guidance; Demonstrated experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development decision-making for regulated medical devices or combination products; Proven experience in HF/UE submissions as well as in successful interactions with regulatory bodies, especially with the US FDA; Strong background in user-centric design, requirements engineering, design controls (CFR 820.30, ISO 13485), risk management (ISO 14971), and applicable global regulatory expectations, including EU MDR; Patient/user advocacy with a solution-oriented mindset; Excellent lateral leadership and communication skills in English; Ability to thrive in a dynamic global matrix environment, embracing change and decision-making. This pivotal role will be at the interface between patients/users, product leadership, commercial, medical/clinical, and engineering teams, ensuring that medical devices and drug-device combination products are designed with the user in mind to enhance safety, effectiveness, and the user experience.