* 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
#J-18808-Ljbffr