Working with us you will receive:

full-time work agreement in an international organization

possibilities for learning and development opportunities, adapted to your needs and supporting your growth

hybrid work model, combining remote work opportunities with work in an office in the City Center

benefits package including social benefits (private medical health care, insurance, sport card, etc.)

Scandinavian culture – we are informal and care about equality, independence, open dialog, and work-life balance

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 projects

Apply today if you:

Hold a higher degree within audiology, health technology/science, or a similar field

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

• 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

Have excellent English skills, both written and spoken

in your day to day tasks keep attention to details