Regulatory Certification Engineer — RF/EMC & Safety

GN Store Nord A/S; Ballerup; On-site; DKK 700,000 - 950,000; Full time

Job summary

GN Store Nord A/S, headquartered in Ballerup, Denmark, seeks a Regulatory Certifications professional to oversee type approvals and guide regulatory strategy across RF, EMC, and safety domains. You will work closely with engineers and project managers to ensure products meet all applicable standards and directives.

You will act as the hearing aid safety subject matter expert, focusing on IEC 60601-2-66 and IEC 60601-1 risk management and usability, while coordinating external labs and

Qualifications

• Bachelor’s or Master’s degree in natural science or engineering.
• Experience with medical devices, radio equipment, and directives, regulations, and standards.
• Attention to detail and ability to manage several projects simultaneously.
• Proactive work style with drive for learning and improvement.
• Fluent in spoken and written English.

Responsibilities

• Oversee and manage Type Approvals and Special Certifications.
• Assist regulatory strategy by determining applicable standards (RF, EMC, safety).
• Collaborate with engineers and project managers to ensure compliance.
• Serve as Subject Matter Expert in hearing aid safety focusing on IEC 60601-2-66 and IEC 60601-1 risk/usability.
• Prepare RF, EMC, and safety test plans and manage type approval in projects.
• Identify external test labs, prepare RFQ, and schedule testing.
• Coordinate Special Certifications toward Bluetooth, Apple, and Google.

Skills

Regulatory compliance

RF testing

EMC testing

Safety testing

Documentation

English communication

Education

Bachelor’s or Master’s degree in natural science or engineering

Job description

GN Store Nord A/S, headquartered in Ballerup, Denmark, seeks a Regulatory Certifications professional to oversee type approvals and guide regulatory strategy across RF, EMC, and safety domains. You will work closely with engineers and project managers to ensure products meet all applicable standards and directives.

You will act as the hearing aid safety subject matter expert, focusing on IEC 60601-2-66 and IEC 60601-1 risk management and usability, while coordinating external labs and