Intelligent Automation in Cancer Care
Clinical Affairs Specialist
Location
United States
Posted
9 days ago
Salary
$120K - $190K / year
Seniority
Senior
Job Description
Clinical Affairs Specialist
Radformation
• 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
Job 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
- 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
- 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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