Clinical Affairs Specialist (Physics)
Remote · United States
Posted on Thursday, November 9, 2023
Work at Radformation
Cancer rates increase year after year, yet high-quality care is not universal. By automating and standardizing the treatment planning workflow, Radformation aims to create a system where any patient anywhere can receive the same high-quality care.
We strive daily to reduce cancer's global impact and help save more of the 10 million lives it claims each year. Our unwavering commitment is to deliver reliable, high-quality, automated solutions that allow clinics to standardized care for every single person in need.
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:
- Assess Clinical Impact of Application Changes
- Develop and execute clinical affairs strategies
- Improve the clinical affairs processes
- Develop process for creating and maintaining globally compliant CER and CEP documentation for entire product line
- Develop Processes for, and execute to create and maintain routine and recurring literature searches and CER Maintenance activities.
- Compiles regulatory submissions
- Provide support to currently marketed products as necessary
- Evaluate technical complaints, and reported issues to assess potential impact to dose, positioning and/or efficacy of treatment.
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.
- Assist in the preparation of regulatory submissions and impact assessments.
- Perform clinical evaluation plans and reports
- Perform literature searches and reviews
- Perform usability evaluation plans and reports
- Assist in validation test protocol and report generation
- 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
- Generate Position Papers, justifying Radformation Product Classification Assessments.
- 5+ years of Radiation Oncology clinic experience as a medical physicist
- PHD\MS Physics or Related Field
- 3+ years of Radiation Oncology software acceptance testing
- Experience with test protocols, clinical evaluations and product qualifications
- Highly motivated
- Strong analytical skills
- Passionate about learning
- Excellent communication and interpersonal skills
- The ability to think strategically, multi-task, and meet deadlines
- The ability to research numerous markets and develop an understanding of and articulate the nuances between segments
- 3+ years of clinical affairs performing clinical evaluation reports
- Experience with Quality Management Systems and ISO 13485
- Experience with the Creation of Clinical Evaluation Plans and Reports under MDR
- Experience with Regulatory Audits
- Direct Radiation Oncology Clinical Support of Treatment Planning systems
What makes us so RAD?
We take care of our people!
Radformation offers top-tier medical, dental, vision care for employees and their families. Each role comes with stock options*, our 401(k) & employer match vest immediately and you'll never have to stress about taking the time you need with self-managed PTO. We support our growing RAD families with generous parental leave, along with additional part-time work to help transition back into the swing of things. We are a fully remote team and while we may be apart, virtual events, yearly retreats and a collaborative work environment keep us close and connected.
Cancer transcends any individual differences we may have. That's why at Radformation we celebrate diversity and are committed to creating an inclusive environment for all employees. We are proud to be an equal opportunity workplace and an affirmative action employer.
*Stock options are offered to US-based employees only.