# Medical Writer / Clinical Specialist

> RetinAI Medical · United Kingdom (Remote) · Full-time · Posted 2026-04-01

**Workplace:** remote

**Department:** Research

## Description

### About Us

[Ikerian AG (formerly RetinAI Medical)](http://www.retinai.com) 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.

## Apply

[Apply at RetinAI Medical](https://apply.workable.com/retinai/j/60AA229109/apply)

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