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Clinical Affairs Specialist

1 month, 1 week ago
United States
Full-time
Senior
Compliance Manager
Operations
Prisma
Apply Now
Radformation

Radformation

Radformation develops innovative software that enhances the efficiency and accuracy of radiation oncology treatment planning by providing a plugin for the Eclipse Treatment Planning System, which evaluates dosimetric constraints and treatment parameter...

Internet Software & Services
51-250
Founded 2016
$8M raised
View All Jobs 9

Description

  • 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 and explain relevant regulations, policies, and 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) and update Annual Post-Market Surveillance Reports.

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 external beam radiation oncology applications and procedures.
  • Ability to write research reports for independent review.
  • Experience with test protocols and clinical evaluations.
  • Highly motivated with strong analytical skills and a passion for learning.
  • Excellent communication and interpersonal skills.
  • 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 CERs for EU-MDR submissions; familiarity with the PRISMA model (preferred).

Benefits

  • Anticipated base salary range of $120,000–$190,000 USD, depending on experience, qualifications, and level.
  • Competitive salary.
  • Immediate health, vision, and dental insurance.
  • Generous paid time off, including self-managed PTO and 10 paid holidays.
  • Multiple high-quality medical plan options with substantial employer contributions toward premiums.
  • Health coverage starting on day one.
  • Short-term and long-term disability coverage plus supplementary life insurance.
  • 401(k) with employer match vested immediately.
  • Annual reimbursement for professional memberships.
  • Conference attendance and continued learning opportunities.
  • Monthly internet stipend.
  • Company-issued laptop and one-time home office setup stipend.
  • Fully remote work environment with virtual events and yearly retreats.

Interested in this position?

Apply directly on the company website

Apply Now

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