About Us

Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.

Job Description

We are looking for a Medical Writer / Clinical Specialist who will collaborate with internal and external stakeholders to prepare clinical study deliverables and clinical documents supporting submissions to regulatory agencies for Software as Medical Devices, including AI-based products. This includes but is not limited to clinical study protocols and reports, investigator brochures, informed consent documents, risk/benefit analysis, PMS/PMCF plan, CEP/CER, Literature review.

Key Responsibilities

• SOP and Process Development: collaborate in writing and maintaining Standard Operating Procedures to ensure organizational alignment with global regulatory standards.
• Technical Documentation: draft and refine Instructions for Use (IFU) and User Manuals to ensure complex AI-based software functionalities are accessible and clear for clinical end-users.
• Clinical Investigation deliverables: prepare critical clinical investigation documents, including Clinical Investigation Plans (CIP), Clinical Investigation Reports (CIR), and Informed Consent Forms (ICF).
• Clinical Evaluation deliverables: prepare Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), including conducting systematic literature reviews to substantiate product safety and performance.
• Post-Market Lifecycle Management: collaborate in the preparation of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) plans and reports, and Periodic Safety Update Reports (PSUR) to maintain regulatory compliance.
• Scientific Communication: Support the company’s clinical evidence strategy by drafting high-quality scientific publications, white papers, and abstracts for international conferences and peer-reviewed journals.
• FDA clinical study design Support