Radformation
Clinical Affairs Specialist - Physicist / Dosimetrist
Remote US
Sponsorship not specified$120k-$190kDetected 21 days ago
AlgorithmsFDA RegulatoryMedical DevicesResearchCommunicationRegulatory Affairs
About the role
- 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.
Responsibilities
- Develop and execute clinical affairs strategies
- Provide support to currently marketed products as necessary.
- Perform clinical evaluation plans and reports
- Perform literature searches and reviews
- Work with regulatory agencies and partners worldwide to achieve market access and compliance.
- Document Compliance with GSPR(s)
Requirements
- 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
- The ability to think strategically, multitask, and meet deadlines
Nice to have
- 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
- Preferred Experience:
Compensation
- The anticipated base salary range for this position is $120,000-$190,000 USD, depending on experience, qualifications, and level.
- Competitive salary
- Annual reimbursement for professional memberships
Benefits
- 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
- Annual reimbursement for professional memberships
- Conference attendance and continued learning opportunities
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