Freelance Medical Writer - Ophthalmology & AI-MDSW (w/m/d)

Our mission is to prevent vision loss and ultimately blindness by developing AI software that assists eye doctors in therapy planning for their patients. We use computer vision deep learning models (AI) trained on thousands of cases and millions of images to predict disease progression, individualize therapy and improve outcomes. The decision support algorithm targets widespread eye diseases like Age-related Macular Degeneration (AMD, 7.5mio affected in Germany alone).

We are looking for an experienced Freelance Medical Writer to help us translate our clinical and technical data into compelling, audit-ready clinical evidence.

• →Lead Clinical Evaluations: You will own the preparation, updates and quality control of our Clinical Evaluation Plans (CEP) and Reports (CER) for our AI-driven products.
• →Synthesize Evidence: You will design systematic literature searches, critically appraise clinical data and produce clear, traceable evidence synthesis.
• →Support PMCF & Publications: You will help plan and report on Post-Market Clinical Follow-up activities, while also translating data into scientific manuscripts and white papers.
• →Connect the Dots: You will act as the crucial link between our R&D, Clinical, and Regulatory teams, ensuring our clinical evidence perfectly aligns with our technical documentation.

• Proven Medical Writing Experience: 5+ years of experience writing for medical devices, ideally with a focus on Software as a Medical Device (SaMD/MDSW) or AI.
• MDR Expertise: Hands-on experience authoring CEPs and CERs under EU MDR requirements, with a solid understanding of how to map intended claims to clinical evidence.
• Scientific Precision: You independently execute systematic literature searches, synthesize complex safety and performance data, and author high-quality scientific publications in fluent English.
• Freelance Mindset: You are highly reliable, proactive and comfortable managing projects and timelines across cross-functional teams.

• Advanced degree (Master/PhD) in a scientific or health-related field.
• Experience in ophthalmology, medical AI, or digital health.
• Proficiency in German (C1).

Ready to build the future of eye care? Please share your availability for upcoming projects, your estimated daily or project-based rates and your CV/LinkedIn profile. We look forward to hearing about your experience in the medical/regulatory space.