Regulatory Certification Engineer, GN Hearing

GN Group; Ballerup; On-site; DKK 700,000 - 900,000; Full time

Job summary

GN Group HQ in Ballerup seeks a Regulatory Certifications specialist to oversee Type Approvals and ensure compliance for medical devices and radio equipment across global markets.

You will define standards, collaborate with engineers, prepare test plans, coordinate labs, and manage certificate renewals, while driving regulatory strategy and risk mitigation.

Qualifications

• Bachelor’s or Master’s degree in natural science or engineering.
• Experience with medical devices, radio equipment, and directives/standards (RFD, EMC, MDR).
• Attention to detail and ability to manage multiple projects.
• Proactive work style and drive for continuous improvement.
• Fluent English in speech and writing.

Responsibilities

• Oversee and manage Type Approvals and Special Certifications.
• Define applicable standards for RF, EMC and safety testing.
• Collaborate with engineers and project managers to perform required testing.
• Prepare test plans and coordinate external labs and quotations.
• Manage renewal of expiring certificates and coordinate Special Certifications (Bluetooth, Apple, Google).

Skills

Regulatory knowledge

Attention to detail

Multitasking

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.

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.

Responsibilities

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.
• Identify and engage external test labs.
• Prepare requests for quotations.
• Prepare schedules for testing.
• Sample- and test SW-testing.
• Gather and review documentation in relation to testing.
• Manage renewal of expiring certificates.
• Coordinate “Special Certifications” towards Bluetooth, Apple, and Google.

Candidate expectations

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.

Equal Employment Opportunity

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.

Special requirements

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.

We hope you will join us on this journey and look forward to receiving your application.

GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history – fostering a sense of community, openness, and understanding. By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.

The GN-owned brands that are responsible for bringing these technologies to life: Medical grade hearing technology: ReSound, Beltone, Interton, Jabra Professional collaboration: Jabra, BlueParrott, FalCom Gaming, calls and media: SteelSeries, Jabra Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN’s solutions are sold in around 100 countries across the world.

If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn, Facebook and Twitter.

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