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).

• →Clinical Evaluation (core assignment): You lead the preparation, update, and quality control of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with Regulation (EU) 2017/745 (EU MDR), Article 61 and Annex XIV, Part A, following the methodological principles of MEDDEV 2.7/1 rev. 4.
• →Literature search & appraisal: You design and document systematic literature searches, appraise clinical evidence, and produce a traceable, audit-ready evidence synthesis suitable for review by our Notified Body.
• →Post-market clinical follow-up: You support PMCF planning and reporting (Annex XIV, Part B) and, where applicable, the SSCP.
• →Scientific publications (secondary): You translate clinical and technical data into scientific manuscripts, research summaries, and white papers for peer-reviewed journals and other channels.
• →Cross-functional collaboration: You act as the link between our clinical, R&D, and regulatory teams, ensuring clinical evidence is accurately reflected in the technical documentation.
• →Documentation standards: You establish project-specific style guidelines and maintain high quality standards, ensuring compliance with relevant regulatory requirements.

• Suitably qualified evaluator: You meet the competency expectations for clinical evaluators, including expertise in the diagnosis and management of the target indication, and your qualifications are documentable (e.g., CV) for Notified Body review in line with EU MDR Annex XIV and MEDDE 2.7/1 rev. 4.
• Working style: Reliable freelancer mindset with strong project management, ability to work with cross-functional stakeholders (Clinical, RA/QA, R&D) and meet timelines.
• Publication support: Demonstrated experience drafting and editing scientific manuscripts/abstracts/posters and other clinical/scientific communications in English.
• Medical device experience (SaMD/digital health preferred): Proven track record (5+ years) in medical writing for medical devices (ideally SaMD/AI) with strong understanding of intended purpose/claims and how they map to clinical evidence.
• Clinical evidence synthesis: Ability to plan and execute (or manage) systematic literature searches, critically appraise clinical data, and synthesize evidence for safety, performance, and clinical benefit; traceable, audit-ready documentation and referencing.
• EU MDR clinical evaluation expertise: Hands-on experience authoring and/or updating Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with Regulation (EU) 2017/745 (EU MDR), incl. MEDDEV 2.7/1 rev. 4 principles, and strong familiarity with MDR requirements for clinical evaluation and clinical evidence (e.g., Annex XIV Part A and Part B; relevant links to Annex II/III where applicable).

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

Please share your availability for upcoming projects, your estimated daily or project-based rates, a link to relevant work samples and your CV/LinkedIn profile. We look forward to hearing about your experience in the medical/regulatory space.