Medical Writer III Job at Intellectt INC, Maple Grove, MN

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  • Intellectt INC
  • Maple Grove, MN

Job Description

Role: Medical Writer III

Location:Maple Grove, MN - 55311

Key Responsibilities

  • Author and review CERs, CEPs, SSCPs, PMS/PMCF Plans & Reports, and other regulatory document
  • Analyze clinical data, literature, and risk documentation for content development
  • Support submissions and responses to notified bodies under MDR
  • Maintain compliance with EU MDR, MEDDEV 2.7.1 Rev. 4, ISO 13485, ISO 14155 , and internal SOPs
  • Collaborate with teams across engineering, clinical, and regulatory domains
  • Bachelor's degree in biomedical sciences, medicine, or related field]
  • 6 8 years of experience in medical or scientific writing (preferably in medical devices or pharma)
  • Hands-on experience writing MDR-compliant CERs/CEPs/SSCPs
  • Knowledge of Structural Heart, Neuromodulation , or similar device areas
  • Strong MS Office proficiency (Word, Excel, PowerPoint)
  • Excellent writing, communication, and analytical skills

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