Clinical Affairs Specialist
About Radformation Radformation creates solutions that detect medical errors and save clinical time for clinicians with a focus on radiation therapy. Using advanced algorithms and optimization techniques, our solutions bring automation to cancer treatments. Currently, many safety checks and planning steps are manually completed. Our goal is to help automate these processes for a more efficient and safer healthcare environment. Our software focuses on three key areas: Time savings through automation. Error reduction through automated systems monitoring patients for errors. Increased quality care through advanced algorithms, creating patient treatment plans that are improved from current manual methods. Why This Role Matters Radformation is seeking a self-motivated Clinical Affairs Specialist to join an innovative team. As Radformation sets out to scale, the Clinical Affairs Specialist will work directly with the VP of Regulatory Affairs to: Develop and execute clinical affairs strategies Improve the clinical affairs processes Compile regulatory submissions Provide support to currently marketed products as necessary. Clinical Affairs is a multidimensional discipline. As part of a smaller team environment, you will have the opportunity to learn and work through clinical aspects of the Clinical Affairs profession. We require that you are coachable and have the drive to become a leader in the Clinical Affairs profession.
Responsibilities
Include: 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 Required Experience: 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 Preferred Experience: 3+ years of clinical affairs experience performing clinical evaluation reports Experience with Quality Management Systems and ISO 13485 Experience writing CEPs and CER’s for EU-MDR Submissions Familiar with PRISMA Model AI & Hiring Integrity At Radformation we believe AI can be an incredible tool for innovation, but our hiring process is all about getting to know you, your skills, experience, and unique approach to problem solving. We ask that all interviews and assessments be completed without tools that generate answers in real time. This helps ensure a fair process for everyone and allows us to see your authentic work. Using such tools during the process may affect your candidacy. Benefits & Perks — What Makes Us RAD We care about our people as much as we care about our mission. We offer competitive compensation, benefits, and the opportunity to make an impact in the fight against cancer. Compensation: The anticipated base salary range for this position is $120,000–$190,000 USD, depending on experience, qualifications, and level. Candidates may be considered for either a Clinical Applications Specialist or Senior Clinical Applications Specialist title based on their clinical radiation oncology experience, technical expertise, and regulatory experience.
Benefits
Competitive salary Immediate Health/Vision/Dental insurance Generous Paid Time Off For US teammates (via TriNet): 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 For global teammates (via Deel): At Radformation, we want every team member to feel supported, no matter where they live. For teammates outside the US, we provide benefits that align with local laws and standards, working with our Employer of Record (EOR) partners to ensure fairness and equity. This means your benefits package will be locally compliant, competitive, and designed to support your health, financial security, and work-life balance. Our Commitment to Diversity Cancer affects people from every walk of life, and we believe our team should reflect that diversity. Radformation is proud to be an equal opportunity workplace and an affirmative action employer. We welcome candidates from all backgrounds and are committed to fostering an inclusive environment for all employees. Agency & Candidate Safety Notice Radformation does not accept unsolicited resumes from agencies without a signed agreement in place. We do not partner with third-party recruiters unless explicitly stated. All legitimate communication from Radformation will come from an @radformation.com email address. If you receive outreach from another domain or via unofficial channels, please contact [email protected]. For more information or to apply, please contact us at [email protected]. \n \n