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