Clinical Affairs Specialist - Physicist / Dosimetrist
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 ann...