Regulatory Compliance Specialist – 12‑Month Parental Leave Cover

About the role

Join GN Hearing’s Regulatory Operations team in Ballerup, Denmark, as a Regulatory Compliance Specialist covering a 12‑month parental leave. You will help ensure hearing‑aid products stay compliant throughout their lifecycle, supporting assessments, product changes and documentation.

Key responsibilities

• Support regulatory compliance activities across the product lifecycle.
• Contribute to regulatory assessments and product change processes.
• Collaborate with cross‑functional teams to improve product development and lifecycle management.
• Identify and implement process improvements, including automation and digital tools.
• Prepare and maintain clear regulatory documentation and support Agile ways of working.

Required profile

• Degree in Engineering or a related technical field.
• Early‑career experience or relevant internships in medical‑device regulation or quality.
• Interest in frameworks such as MDR, FDA, ISO 13485, IEC 62304 or IEC 62366.
• Structured, risk‑based approach with strong analytical mindset.
• Excellent written and spoken English and ability to communicate technical topics to varied audiences.

Required skills

• Python programming.
• Power Automate and Power BI for automation.
• Familiarity with AI tools that support efficiency.
• Agile or Scrum ways of working.