Medical Writer - Clinical Evaluation

We are looking for a Medical Writer - Clinical Evaluation to join our Product Research Team. In this role, you will ensure that the clinical evaluation documentation for Nox Medical products meets regulatory requirements. You will work in close collaboration with other team members at the intersection of clinical research, product development, and regulatory science.

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.