Clinical Affairs Specialist
About The Position
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.
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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- Competitive salary
- Immediate Health/Vision/Dental insurance
- Generous Paid Time Off
- 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
- 401(k) with employer match vested immediately
- Annual reimbursement for professional memberships
- Conference attendance and continued learning opportunities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
