Regulatory Certification Engineer (Medical Devices)

Location: Ballerup, Denmark; headquarters position

Company

hirify.global develops intelligent hearing, audio, video, and gaming solutions, including advanced hearing aids and other technologies that enhance hearing and sight.

What you will do

• Oversee type approvals and special certifications for new and existing products.
• Determine applicable requirements for radio frequency, EMC, safety, and medical-device compliance.
• Prepare RF, EMC, and safety test plans and manage testing activities throughout development projects.
• Identify and coordinate external test laboratories, quotations, testing schedules, samples, software testing, and technical documentation.
• Renew expiring certificates and coordinate special certifications involving Bluetooth, Apple, and Google.
• Act as a subject matter expert in hearing-aid safety, with focus on IEC 60601-2-66, IEC 60601-1, risk management, and usability.

Requirements

• Bachelor’s or Master’s degree, or equivalent, in natural science or engineering.
• Experience with medical devices and radio equipment.
• Strong understanding of directives, regulations, and standards, including the Radio Equipment Directive, EMC Directive, MDR, and international standards.
• Ability to manage multiple projects and tasks, follow through to closure, and drive continuous improvement.
• Spoken and written English required.

Culture & Benefits

• Work from the central headquarters with colleagues and external stakeholders across global, regional, and local markets.
• Collaborate with engineers and project managers within Global R&D and Corporate Quality.
• Contribute to the direction, development, and strategy of a growing Regulatory Certifications Team.
• Inclusive recruitment process with equal consideration for all applicants.

Hiring process

• Submit an up-to-date CV and a few sentences explaining motivation for applying.
• Applications are assessed continuously; the application deadline is September 15, 2025.
• Interview accommodations can be requested when accepting an interview invitation.