Clinical Affairs Specialist

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Radformation

WebsiteLinkedInAll Job Openings

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

💰 Seed Round on 2019-10

Healthcare Insurance • Artificial Intelligence • SaaS

Radformation is a company that specializes in intelligent automation for cancer care, offering software that enables cancer clinics to enhance their efficiency and accuracy. They provide a range of products such as AutoContour for automated AI contouring and EZFluence for 3D planning, as well as tools for plan evaluation, independent calculations, and machine quality assurance. Radformation aims to streamline clinical workflow from planning and documentation to treatment evaluations and billing, thus improving plan quality, safety, and efficiency in cancer treatment. Their solutions are designed to integrate seamlessly with existing technology, helping clinics improve their patient care.

📋 Description

• 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

🎯 Requirements

• 3+ years of Radiation Oncology clinic experience as a medical physicist, medical physics assistant, or dosimetrist • Ability to research journals, papers, and publications to identify current state of the art as it relates to external beam radiation oncology applications and procedures. • Ability to write research reports for independent review. • Experience with test protocols and clinical evaluations • Highly motivated • Strong analytical skills • Passionate about learning • Excellent communication and interpersonal skills • The ability to think strategically, multitask, and meet deadlines • 3+ years of clinical affairs experience performing clinical evaluation reports (preferred) • Experience with Quality Management Systems and ISO 13485 (preferred) • Experience writing CEPs and CER’s for EU-MDR Submissions (preferred) • Familiar with PRISMA Model (preferred)

🏖️ Benefits

• Competitive salary • Immediate Health/Vision/Dental insurance • Generous Paid Time Off • Health & Wellness • Multiple high-quality medical plan options with substantial employer contributions toward premiums, often covering the full cost depending on the plan selected. • Health coverage starting on day one • Short-term and long-term disability and supplementary life insurance • Financial & Professional Growth • 401(k) with employer match vested immediately • Annual reimbursement for professional memberships • Conference attendance and continued learning opportunities • Work-Life Balance & Perks • Self-managed PTO and 10 paid holidays • Monthly internet stipend • Company-issued laptop and one-time home office setup stipend • Fully remote work environment with virtual events and yearly retreats, because we like to have fun while doing work that matters • Benefits that align with local laws and standards for global teammates.