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About the role
- 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
Requirements
- higher degree within audiology, health technology/science, or a similar field
- documented professional experience working with hearing aids or other medical devices (EU MDR class IIa or higher)
- 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
- excellent English skills, both written and spoken
- attention to details
Benefits
- 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
- flexible working hours
- 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