Lifecycle Regulatory Specialist – Medical Devices

GN Group; Ballerup; On-site; DKK 650,000 - 850,000; Full time

Job summary

GN Hearing is seeking a Regulatory Product Compliance Specialist to help ensure hearing aid products stay compliant throughout their lifecycle. You will support regulatory assessments, product changes, documentation and process improvements in a collaborative, global team located at GN’s headquarters in Ballerup, Denmark.

The role emphasizes lifecycle compliance for hearing aids across new and in-market devices, working within MDR, FDA, ISO standards, and other regulatory frameworks.

Qualifications

• Interest in medical device regulation and quality.
• Ability to communicate regulatory concepts to diverse audiences.
• Structured, risk-based approach to work.

Responsibilities

• Support regulatory compliance activities across the product lifecycle.
• Contribute to regulatory assessments and product change activities to maintain compliance.
• Collaborate with cross-functional teams to support product development and lifecycle improvements.
• Contribute to process improvements and efficient day-to-day ways of working.
• Identify opportunities to automate and streamline tasks using digital tools and AI where relevant.
• Support Agile ways of working and maintain audit-ready documentation.

Skills

English proficiency

Regulatory knowledge

Agile / Scrum

Regulatory documentation

Education

Engineering degree or relevant technical field

Job description

GN Hearing is seeking a Regulatory Product Compliance Specialist to help ensure hearing aid products stay compliant throughout their lifecycle. You will support regulatory assessments, product changes, documentation and process improvements in a collaborative, global team located at GN’s headquarters in Ballerup, Denmark.

The role emphasizes lifecycle compliance for hearing aids across new and in-market devices, working within MDR, FDA, ISO standards, and other regulatory frameworks.