About RadformationRadformation 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 MattersRadformation 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 strategiesImprove the clinical affairs processesCompile regulatory submissionsProvide 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 reportsPerform literature searches and reviewsWork 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 ReportsRequired Experience:3+ years of Radiation Oncology clinic experience as a medical physicist, medical physics assistant, or dosimetristAbility 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 evaluationsHighly motivatedStrong analytical skillsPassionate about learningExcellent communication and interpersonal skillsThe ability to think strategically, multitask, and meet deadlinesPreferred Experience:3+ years of clinical affairs experience performing clinical evaluation reportsExperience with Quality Management Systems and ISO 13485Experience writing CEPs and CER’s for EU-MDR SubmissionsFamiliar with PRISMA ModelAI & Hiring IntegrityAt 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 RADWe 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.BenefitsCompetitive salaryImmediate Health/Vision/Dental insuranceGenerous Paid Time OffFor US teammates (via TriNet):Health & WellnessMultiple 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 oneShort-term and long-term disability and supplementary life insuranceFinancial & Professional Growth401(k) with employer match vested immediatelyAnnual reimbursement for professional membershipsConference attendance and continued learning opportunitiesWork-Life Balance & PerksSelf-managed PTO and 10 paid holidaysMonthly internet stipendCompany-issued laptop and one-time home office setup stipendFully remote work environment with virtual events and yearly retreats, because we like to have fun while doing work that mattersFor 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 DiversityCancer 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.

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Clinical Affairs Specialist

Emma

Requirements and responsibilities

Skills wanted:

Language(s) required:

Kurt Sysock

Kurt Sysock

About Radformation:

mission:

www.radformation.com/

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