Act as functional interface to the Project Management Office for regulatory needs Manage the RA task backlog and ensure resource planning in coordination with the Director of RA Provide regulatory expertise across domain and release projects Drive execution of RA management decisions Proactively identify and lead continuous improvement opportunities Support the development of departmental strategies and training Represent RA in roadmap discussions and cross-functional planning Participate in PI planning and raise regulatory actions for planning cycles Ensure adherence to global regulatory and safety requirements Support worldwide regulatory submissions including FDA, Health Canada, Japan, and China Deputize for RA Director and substitute for RA engineers when needed Strong leadership and conflict resolution abilities Ability to influence and build strong cross-functional relationships Effective communication skills at all organizational levels Collaborative mindset with the ability to mentor and drive problem-solving Structured, detail-oriented and able to work independently Positive attitude toward change and continuous improvement At least 7 years of experience in Regulatory Affairs within the medical device industry Proven project or program management experience, preferably in Agile environments Experience with radiotherapy or radiosurgery is a plus Familiarity with international regulatory standards and submissions BSc or MSc in Engineering or equivalent Experience with quality assurance, compliance, and audits Proficient in Microsoft Office and common IT tools Excellent English language skills (written and verbal) Experience working in a multicultural environment