Regulatory Certification Engineer, GN Hearing

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

Would you like a central headquarter position, collaborating with colleagues and external stakeholders across the world to ensure smooth and efficient market access? As a global leader in intelligent audio solutions, GN provides people across the world with advanced hearing aids that let you hear more, do more, and be more than you ever imagined.

The Team you will be part of:

At HQ in Ballerup, you will become part of the Regulatory Certifications Team within Corporate Quality. As part of Global R&D, we make sure that new and existing products obtain market access across our global, regional, and local markets. Our team is rapidly growing, and you will have a great opportunity to assist in setting the direction and contribute to the team’s further development and strategy to ensure we deliver to GN’s overall strategy.

Your contribution is appreciated, and you will:

• Oversee and manage Type Approvals and Special Certifications.
• Provide valuable input to the regulatory strategy by determining applicable standards within the areas of Radio frequency-, EMC- and safety-testing.
• Be deeply involved in development projects, working closely with our skilled Engineers and Project Managers to ensure our products conform to the requirements of applicable standards, directives, and regulations by conducting relevant and meaningful testing.
• The ideal candidate will take on the responsibility of being the Subject Matter expert in hearing aid safety and will have an extended knowledge of the IEC 60601-2-66 standard and the interrelation with IEC 60601-1 with focus on risk management and usability.

More specifically you will:

• Determine applicable standards.
• Prepare RF-, EMC-, and safety test plans.
• Manage the type approval process in development projects by:
• Identifying and engaging external test labs.
• Preparing requests for quotations.
• Preparing schedules for testing.
• Sample- and test SW-testing.
• Gathering and reviewing documentation in relation to testing.
• Manage renewal of expiring certificates.
• Coordinate “Special Certifications” towards Bluetooth, Apple, and Google.

To perform well in the role, we imagine that you:

• Have a Bachelor’s or Master’s degree or similar within natural science or engineering.
• Have experience working with medical devices, radio equipment, and a thorough understanding of directives, regulations, and standards such as Radio Equipment Directive, EMC directive, MDR, and various international standards.
• Have a keen eye for details and the ability to work on several projects/tasks simultaneously.
• Work proactively, follow through, ensure project closure and drive learnings and continuous improvement.
• Communicate effortlessly in spoken and written English.

We are focused on an inclusive recruitment process

All applicants will receive equal consideration for employment. As such, we encourage you to submit your CV without a photo to ensure an equal and fair application process.

Should you have any special requirements for the interview, please let the Hiring Manager know upon accepting invitation to interview.

Join us in Bringing People Closer:

GN brings people closer through our advanced intelligent hearing, audio, video, and gaming solutions. Inspired by people and motivated by innovation, we deliver technology that enhances the senses of hearing and sight. We enable people with hearing loss to overcome real-life problems, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN Store Nord A/S has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. to create a global leader in audiology. For GN Group, this creates an opportunity to expand our position in the large audio and video peripherals markets. Read more about the announcement here.

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Location: Ballerup