Medical Writer - Clinical Evaluation

What You’ll Do

As a Medical Writer - Clinical Evaluation, your key responsibilities include:

• Author and maintain Clinical Evaluation documents to ensure compliance with regulatory requirements, including MDD, MDR, and FDA frameworks, in collaboration with other PRT members, Quality and Regulatory, and other R&D teams. 
• Conduct comprehensive literature searches and data extraction of scientific publications related to Nox Medical products, the State-of-the-Art, and Biological Evaluation in collaboration with other PRT members.
• Critically appraise clinical data to assess its scientific validity, relevance, and level of evidence.
• Support the transition of existing documentation and processes from MDD to MDR, ensuring clear traceability, alignment with current requirements, and elimination of legacy inconsistencies.
• Contribute to assessing the need for PMCF activities, maintaining PMCF Plans, and preparing PMCF Evaluation Reports in collaboration with internal stakeholders. 
• Participate in process and efficiency improvements by leveraging new technologies, automation, and AI-based tools for literature review, data extraction, and document authoring to streamline workflows and improve documentation quality.

What You Bring

Education and Experience:

• Master's degree in Life Sciences, Medicine, Biomedical Engineering, or a related scientific discipline, or equivalent experience.
• Experience in the medical device or pharmaceutical industry, with exposure to regulatory or clinical affairs.
• Demonstrated experience in authoring Clinical Evaluation Reports (CERs) and related documentation under MDR/MDD (highly advantageous).
• Experience with literature searches, scientific appraisal, and systematic review methods.
• Familiarity with key medical device regulations, standards, and guidance (e.g., EU MDR highly advantageous; FDA experience advantageous but not required).

Technical & Professional Skills:

• Strong analytical and scientific writing skills with excellent command of English.
• Proficiency with scientific literature tools (PubMed, Embase) and reference management software (e.g., Zotero), as well as Microsoft Office.
• Comfortable following standard operating procedures (SOPs) and working with predefined templates.
• Demonstrates curiosity and capability in adopting technical and innovative approaches, including automation and AI-based tools, to streamline workflows and improve documentation quality.
• Strong attention to detail, critical thinking, and ability to work collaboratively across multidisciplinary teams.
• Motivated by continuously learning and applying newly found knowledge to work.

Why Join Nox Medical

At Nox Medical, you’ll join a diverse team of scientists, engineers, and innovators dedicated to advancing sleep diagnostics through cutting-edge technology and research.
You’ll play a key role in developing solutions that empower healthcare professionals and improve patient outcomes — all within a culture that values collaboration, curiosity, and continuous learning.