Note: The job is a remote job and is open to candidates in USA. Radformation is an innovative company focused on automating cancer treatments to improve healthcare efficiency. They are seeking a Clinical Affairs Specialist to develop and execute clinical affairs strategies, improve processes, and support regulatory submissions.

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

Skills

• 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
• Experience with Quality Management Systems and ISO 13485
• Experience writing CEPs and CER's for EU-MDR Submissions
• Familiar with PRISMA Model

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, because we like to have fun while doing work that matters

Company Overview