Senior Medical Writer

Senior Medical Writer
Are you passionate about medical writing and ensuring regulatory compliance in the medical device industry? Do you want to play a key role in creating clinical documentation that supports patient safety and innovation?

As part of our Clinical Affairs team, you will contribute to the development and maintenance of clinical evaluations and Post-Market Clinical Follow-up (PMCF) documentation for our hearing solutions portfolio. You will work closely with internal stakeholders and external authorities to ensure compliance with EU MDR and other regulatory requirements. As a Senior Medical Writer, you’ll combine scientific expertise with regulatory knowledge—delivering high-quality clinical documentation and acting as a trusted advisor within the organization.

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
  
  
• 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
  
  

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
  
  

Please send your CV in English.

If you have any questions, contact the recruiter: Jakub [xxxxx].com)

◀ Furthermore we would like to inform you that the company has an internal reporting procedure, which is available at: [xxxxx]compliance - Make a report (codeofconduct.app)

#LI-HYBRID #LI-JW1 #[xxxxx]_Poland