Freelance Technical Writer (m/f/d) – Medical Technology / Regulatory Documentation

CorLector GmbH; Deutschland; Remote; EUR 55.104 - 96.432; Teilzeit

Benefits dieser Stelle

Projets passionnants

Collaboration entièrement à distance

Gestion du temps flexible

Rémunération équitable par accord

Zusammenfassung

Une start-up innovante de technologie médicale recherche un rédacteur technique freelance pour créer des documents réglementaires destinés aux approbations MDR et FDA. Vous travaillerez en étroite collaboration avec une équipe interdisciplinaire pour assurer la qualité et la conformité des documents. Ce poste offre la flexibilité du travail à distance et vous permettra de contribuer à des projets passionnants à l'interface de l'innovation et de la réglementation.

Qualifikationen

• Expérience en rédaction technique, idéalement dans le secteur médical.
• Connaissance approfondie des exigences MDR et FDA.
• Capacité à travailler de manière indépendante et structurée.

Aufgaben

• Créer et maintenir la documentation technique pour les approbations MDR et FDA.
• Collaborer étroitement avec les départements de développement et de qualité.
• Assurer la conformité avec les normes et exigences réglementaires.

Kenntnisse

Rédaction technique

Connaissance des exigences réglementaires

Gestion de documents

Connaissance des outils tels que Confluence et Git

Anglais et Allemand

Tools

Confluence

Markdown

Git

DITA

Jobbeschreibung

Freelance Technical Writer (m/f/d) – Medical Technology / Regulatory Documentation

Germany

Freelance Technical Writer (m/f/d) – Medical Technology / Regulatory Documentation

Remote | Start: immediately | Project-based / by arrangementAbout usWe are an innovative MedTech start-up (CorLector GmbH) based in Nuremberg that develops software solutions for cardiology. Our products are about to be approved, which is why we rely on high-quality, standard-compliant documentation. To support our team, we are looking for an experienced technical writer (freelance) to help us create and maintain regulatory documents.Your tasks

• Creating, revising and maintaining technical documentation for MDR and FDA approvals.
• Structuring and editing documents such as instructions for use, risk management documents, clinical evaluations and software documentation.
• Working closely with the development, regulatory affairs and quality management departments.
• Ensuring compliance with applicable standards and regulatory requirements (e.g. ISO 13485, IEC 62304, ISO 14971).
• Supporting the optimization of our documentation processes and structures.

Your profile

• Several years of experience in technical writing, ideally in the medtech or life science environment.
• Profound knowledge of regulatory requirements in the area of MDR and FDA.
• Confident handling of technical and regulatory texts in German and English.
• Independent, structured and conscientious way of working.
• Experience with tools such as Confluence, Markdown, Git, DITA or similar is an advantage.
• Availability for project-based work, flexible and remote.

We offer

• Exciting projects at the interface of innovation and regulation.
• Working with a dedicated, interdisciplinary team.
• Clear communication, short decision-making paths and realistic timelines.
• Flexible time management and fully remote collaboration.
• Fair remuneration by agreement.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Other

Job function

• Job function

  Marketing, Public Relations, and Writing/Editing

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