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