Radformation

QA Engineer

• Ensure product quality by thoroughly testing new versions of AutoContour prior to release
• Execute verification and validation (V&V) testing to maintain product integrity and performance
• Partner with Success and Support teams to troubleshoot issues and support clinic implementations
• Provide actionable feedback to Product and Engineering to improve functionality and usability
• Support regulatory and medical device documentation, including requirements definition, risk mitigation, and test documentation

Quality Assurance Manager

Sales

• Generate and support new sales opportunities across the EMEA territory
• Collect key information about the prospect’s install base and clinical needs to nurture sales opportunities
• Document all conversations, appointments, and meetings in Salesforce
• Coordinate post-webinar, trade show, and customer visit follow-ups to advance opportunities
• Leverage clinical experience to communicate with potential customers via various methods (virtual and in-person)
• Build rapport, identify clinical and operational pain points, and act as a trusted advisor
• Participate in regular territory reviews to gather updates for existing opportunities and pursue new additions to the sales pipeline
• Conduct presentations on Radformation software, including slide shows and live demonstrations at events and customer visits
• Collaborate with Account Managers to appropriately progress qualified opportunities
• Support transition of closed accounts to the Clinical Success team

Clinical Sales Specialist – EMEA

Compliance

• Coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices
• Perform Regulatory Impact Assessments to determine registration implications for proposed product and design changes
• Prepare and submit international regulatory filings in alignment with established timelines and business objectives
• Lead and author 510(k) submissions, including applicable technical and regulatory content
• Represent Regulatory Affairs on cross-functional projects and provide regulatory guidance throughout development and change management
• Collaborate with internal teams to implement and improve regulatory processes, including registration tracking, reporting, and status management
• Monitor global regulatory changes and assess their impact on submission strategies and existing registrations
• Interact with regulatory authorities as needed during submission and review processes
• Coordinate with international partners on product changes, regulatory notifications, and license maintenance
• Author or revise SOPs to support ongoing quality system and regulatory compliance
• Support audit readiness and other regulatory or quality-related initiatives as assigned

Quality Assurance Manager

Clinical Sales Specialist – EMEA

Senior Regulatory Affairs Specialist