Medical Writer

What tasks are waiting for you?

• Write and maintain clinical evaluations and PMCF documents in compliance with EU MDR and internal standards


• Monitor, evaluate, and implement regulatory requirements related to Clinical Affairs, including Clinical Evaluation and PMCF


• Ensure the level of clinical evidence required to achieve regulatory compliance for assigned products


• Communicate clinical evidence needs and results to internal stakeholders across the organization


• Represent Clinical Affairs towards external parties, such as competent authorities


• Make content decisions on clinical evaluations and PMCF documents


• Act as a Subject Matter Expert within the Clinical Affairs area


• Make project‑related decisions for Clinical Affairs project

Apply today if:

• you hold a higher degree within audiology, health technology/science, or a similar field


• you have documented professional experience working with hearing aids or other medical devices (EU MDR class IIa or higher)


• you possess knowledge of and preferably experience with:
  – research methodology
  – information management
  – regulatory requirements
  – medical writing
  – preparing clinical evaluation plans and reports for at least EU MDR class IIa (active) medical devices
  – device technology and application
  – diagnosis and treatment options for hearing conditions covered by the devices being evaluated


• you have excellent English skills, both written and spoken


• in your day‑to‑day tasks you keep attention to details

If you have any questions, contact the recruiter: Jakub ([email protected])

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