Clinical Affairs Specialist

Radformation

Clinical Affairs Specialist at Radformation developing regulatory strategies and improving clinical affairs processes for automated radiation therapy solutions. Collaborating with the VP of Regulatory Affairs and managing submissions.

Posted 7/1/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $190,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
3+ years of clinical affairs experience performing clinical evaluation reports (preferred)
Experience with Quality Management Systems and ISO 13485 (preferred)
Experience writing CEPs and CER’s for EU-MDR Submissions (preferred)
Familiar with PRISMA Model (preferred)

Benefits

Comp & perks

Competitive salary
Immediate Health/Vision/Dental insurance
Generous Paid Time Off
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
Benefits that align with local laws and standards for global teammates.

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Evaluation PlansTechnical ReviewTest ProtocolsResearch Report WritingImpact Assessments

Soft Skills

Analytical SkillsExcellent CommunicationInterpersonal SkillsStrategic ThinkingMultitasking