[Hiring] Medical Writer / Clinical Specialist @RetinAI Medical

Role 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.

Qualifications

• 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.
• 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

• 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.