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Medical Writer / Clinical Specialist

3 weeks, 6 days ago
Spain, United Kingdom
Full-time
Senior
Technical Writer
Project and Program Management
Apply Now
Retinai

Retinai

RetinAI accelerates ophthalmology workflows with AI-driven insights, optimizing patient outcomes and research processes.

Internet Software & Services
11-50
Founded 2017
$3M raised
View All Jobs 5

Description

  • Collaborate with internal and external stakeholders to prepare clinical study deliverables and regulatory clinical documents for software as a medical device.
  • Draft and maintain Standard Operating Procedures to support organizational alignment with global regulatory standards.
  • Prepare and refine Instructions for Use and User Manuals for AI-based software products.
  • Develop clinical investigation documents, including Clinical Investigation Plans, Clinical Investigation Reports, and Informed Consent Forms.
  • Prepare clinical evaluation deliverables, including Clinical Evaluation Plans and Clinical Evaluation Reports, and conduct systematic literature reviews.
  • Support post-market lifecycle management by preparing PMS, PMCF, and PSUR plans and reports.
  • Draft scientific publications, white papers, abstracts, and other materials to support the company’s clinical evidence strategy.
  • Support FDA clinical study design activities, including 510(k) and/or De Novo pathway submissions.

Requirements

  • University degree in Biomedical Engineering, Pharmacy, or a similar field.
  • Minimum 5 years of relevant work experience, including 2 to 3 years in a medical device company.
  • Strong understanding of EU MDR (EU) 2017/745, ISO 14155, ICH E6 (R3), 21 CFR Part 812, MEDDEV 2.7.1/rev. 4, and relevant MDCG guidelines.
  • Previous experience supporting FDA clinical study design, including FDA 510(k) and/or De Novo pathways.
  • Proven project management skills.
  • Strong communication skills and ability to manage internal and external stakeholders.
  • High interpersonal skills and ability to work autonomously with a high degree of self-direction.
  • Experience in ophthalmology is a plus.
  • Experience with AI in medicine is a plus.
  • Fluency in English.
  • Proficiency with Microsoft Office and/or Google G Suite tools, including Word, Excel, PowerPoint, Docs, Sheets, and Slides.
  • Willingness to travel occasionally, up to 4 events per year.

Benefits

  • Competitive salary in a supportive work environment that promotes work-life balance.
  • Opportunities for professional growth and development in an international setting.
  • A collaborative and inclusive company culture.
  • Chance to join a team driving innovation in healthcare.
  • Occasional travel to the company headquarters in Switzerland to connect with core operations and company culture.

Interested in this position?

Apply directly on the company website

Apply Now

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