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
Requirements
- University degree in Biomedical Engineering, Pharmacy, or similar.
- Minimum of 5 years relevant work experience, thereof 2 to 3 years of experience in a medical device company and a good understanding of Regulation (EU) 2017/745 (EU MDR), ISO 14155 standard requirements, ICH E6 (R3) Guideline for good clinical practice (GCP) and 21 CFR Part 812, as well as MEDDEV 2.7.1/rev4 and MDCG guidelines related to clinical evaluation and post-market surveillance
- Previous experience with FDA clinical study design support (i.e FDA 510k and/or FDA Denovo pathway)
- Proven project management skills
- Strong communicator with proven ability to manage and communicate with internal and external stakeholders
- High level of interpersonal skills
- Self-starter with a high degree of autonomy
- Experience in the Ophthalmology field is a plus
- Experience with AI in medicine is a plus
- Fluency in English
- Skilled in the use of Microsoft Office and/or Google G-suite applications (Word, Excel, PowerPoint and / or Docs, Sheets, Slides).
- Willingness to travel occasionally (up to 4 events per year).
Benefits
What We Offer
- A chance to be part of an exceptional team driving innovation in healthcare.
- A competitive salary in a supportive work environment that fosters work-life balance.
- Opportunities for professional growth and development in an international setting.
- A culture of collaboration and inclusion, which is fundamental to our ethos.
- Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture.