Radformation

• Assist in the preparation of regulatory submissions and impact assessments. • Perform clinical evaluation plans and reports • Perform literature searches and reviews • Work with regulatory agencies and partners worldwide to achieve market access and compliance. • Comply with the quality management system and ISO 13485. • Ensure compliance with regulations. • Explain regulations, policies, or procedures. • Provide technical review of data and reports. • Coordinate clinical documentation activities. • Update Clinical Evaluation Reports on an annual basis. • Document Compliance with GSPR(s) • Update Annual Post-Market Surveillance Reports

• Work with clinics to understand their technical issues and provide solutions independently and/or with the help of the Engineering team. • Support the Sales and Success teams by installing and upgrading Radformation software at customer sites. • Work directly with hospital IT departments as the technical expert representative during implementations and upgrades. • Complete IT documents and vendor security questionnaires requested by customer hospitals. • Meet with clinics to discuss installation planning, system architecture, and cybersecurity requirements. • Aid the Clinical Customer Support Representatives as needed. • Assist team members in troubleshooting internal IT issues.

• Design, develop, and maintain features supporting adaptive radiotherapy workflows: DICOM integration, image registration, dose visualization, DVH evaluation, and machine positioning • Build and optimize algorithms for 3D image processing, coordinate transforms, deformable registration, and dose sampling on deformed anatomy • Develop performant, reliable WPF desktop software operating under near real-time constraints. • Integrate with oncology information systems via DICOM networking and related clinical interfaces • Collaborate with physicists and product leaders to translate clinical requirements into production software • Contribute to architecture, testing, code reviews, and technical decision-making • Support teammates through collaboration, mentorship, and knowledge sharing

• Develop and execute the commercial strategy for EMEA, including market prioritization, territory planning, channel strategy, and resource allocation. • Own bookings, pipeline generation, forecast accuracy, and revenue growth throughout the EMEA region. • Collaborate with our Channel Manager to optimize distributor performance across EMEA. • Evaluate, develop, and hold distributors accountable for revenue performance, pipeline development, and market coverage. • Develop, train, and support distributor teams to maximize product knowledge, pipeline generation, and revenue performance. • Recruit, develop, and manage Regional Account Managers and Clinical Sales Specialists as the EMEA organization scales. • Manage direct sales activities in markets not covered by distributor partnerships. • Develop relationships with key opinion leaders, strategic reference sites, and leading academic institutions throughout EMEA. • Increase Radformation’s brand awareness and market presence through strategic marketing initiatives, customer advocacy programs, conference participation, and distributor enablement. • Develop and execute organizational growth plans for EMEA, including recruiting, training, and identifying regional support requirements. • Coordinate with Regulatory Affairs on market clearance activities and regional expansion priorities. • Travel throughout EMEA to support customers, distributors, conferences, and business development initiatives.

• Lead Radformation’s commercial growth strategy throughout the LATAM region • Drive revenue expansion through both direct sales and distributor partnerships • Develop and execute the commercial strategy for LATAM, including market prioritization, territory planning, channel strategy, and resource allocation • Own bookings, pipeline generation, forecast accuracy, and revenue growth throughout the LATAM region • Collaborate with our Channel Manager to optimize distributor performance across LATAM • Evaluate, develop, and hold distributors accountable for revenue performance, pipeline development, and market coverage • Develop, train, and support distributor teams to maximize product knowledge, pipeline generation, and revenue performance • Recruit, develop, and manage Regional Account Managers and Clinical Sales Specialists as the LATAM organization scales • Manage direct sales activities in markets not covered by distributor partnerships • Develop relationships with key opinion leaders, strategic reference sites, and leading academic institutions throughout LATAM • Increase Radformation’s brand awareness and market presence through strategic marketing initiatives, customer advocacy programs, conference participation, and distributor enablement • Develop and execute organizational growth plans for LATAM, including recruiting, training, and identifying regional support requirements • Coordinate with Regulatory Affairs on market clearance activities and regional expansion priorities • Travel throughout LATAM to support customers, distributors, conferences, and business development initiatives

• Develop and execute Radformation's international growth strategy, including market prioritization, channel strategy, headcount planning, budget and resource allocation, pricing and packaging, and expansion initiatives. • Lead and continue building Radformation’s international sales organization, with a focus on EMEA, APAC, and LATAM markets. • Own international bookings, pipeline generation, forecast accuracy, and annual operating plan performance. • Lead, coach, and develop international sales leaders and team members to drive performance and growth. • Build relationships with clinics and key stakeholders to expand Radformation’s global software user base. • Continue building and strengthening our international distribution network. • Assist with global distributor and channel partner strategy, including recruitment, onboarding, enablement, performance management, and contract negotiations. • Serve as the primary interface between International Sales, Marketing, Success, Support, and Product teams. • Own global regulatory submission prioritization and coordination with the Regulatory Affairs team. • Aggregate product feedback, competitive intelligence, and clinical insights from all regions to influence the product roadmap. • Develop global product messaging, value propositions, playbooks, and core processes that can be adapted for regional markets. • Lead and support clinical evidence and key opinion leader initiatives with strategic sites and partners to support growth and adoption. • Participate in the presentation of Radformation software through trade shows, onsite demonstrations, webinars, and remote screen shares.

• Testing product versions prior to release to aid in quality assurance using C# in Visual Studio. • Version verification and validation testing to ensure product quality and integrity. • Coordination with the Success and Support teams for troubleshooting assistance and/or clinic setup. • Sharing feedback with the Product Manager and engineering team. • Documentation generation for product-related materials. • Medical Device documentation preparation, in cooperation with our Regulatory team, including defining requirement specifications, outlining testing conditions, executing and documenting testing, and outlining and mitigating software risks.

• Develop and maintain full stack functionality for the ChartCheck application across frontend and backend systems • Design and implement scalable web and cloud-based software solutions using C# and JavaScript technologies • Collaborate with cross-functional teams to create innovative software products for cancer treatment centers • Participate in thoughtful code reviews and contribute to maintaining high software quality standards • Track and manage development work clearly and independently through tickets and project workflows • Support teammates through knowledge sharing, collaboration, and mentorship • Contribute to secure and compliant software development practices within healthcare environments

• Support feature prioritization and define product specifications based on customer and clinical needs • Coordinate and manage product releases, including associated requirements and timelines • Test new product versions and features prior to release, including regression testing to ensure product integrity • Investigate and help resolve issues identified during testing and by clinical users • Partner with Support and Customer Success teams to troubleshoot complex customer issues • Share feedback and insights with Product, Engineering, and leadership to inform ongoing improvements • Support regulatory and quality requirements for a medical device product, partnering with internal stakeholders as needed

• Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance. • Lead the construction and execution of both formative and summative usability activities for SaMD applications • Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability • Work with customer contact and product application specialists to oversee the execution of Usability studies • Map existing Clinical Deliverables to global requirements for clinical evidence and reporting • Drive execution of PMCF and PMS activities and reporting • Represent Radformation in Compliance Audits and Conformity Assessments, specifically regarding usability and Clinical documentation • Author or revise SOPs to improve regulatory compliance of the Quality System