Senior Specialist, Regulatory Affairs to GN Hearing

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

Job summary

GN Group seeks a Senior Specialist, Regulatory Affairs to drive strategic regulatory initiatives and maintain compliance for our medical devices used in hearing loss treatment across global markets.

You will work with R&D, Quality, and Commercial teams to enable innovation while aligning with EU MDR and MDSAP requirements throughout the product lifecycle.

Qualifications

• Solid direct experience in Regulatory Affairs for global medical devices.
• Knowledge of EU MDR and MDSAP requirements.
• Experience with regulatory submissions and change management.
• Ability to translate regulatory requirements into clear guidance for stakeholders.
• Willingness to collaborate across R&D, Quality, and Commercial teams.

Responsibilities

• Support key regulatory initiatives within Regulatory Affairs.
• Help ensure regulatory compliance for medical devices across global markets, with focus on EU MDR and MDSAP.
• Contribute to regulatory activities across the product lifecycle, including assessments, submissions, registrations, and change management.
• Collaborate with cross-functional stakeholders in R&D, Quality, and Commercial teams.
• Act as a trusted regulatory partner by translating complex regulatory requirements into clear and practical guidance.

Skills

Regulatory affairs

EU MDR

MDSAP

Regulatory submissions

Cross-functional collaboration

Job description

In the role of Senior Specialist, Regulatory Affairs, part of Corporate Quality, you will contribute to our purpose of Bringing People Closer. You will support strategic regulatory initiatives and ensure continued regulatory compliance for our medical devices used in the treatment of hearing loss across global markets. This is an exciting opportunity to join a purpose-driven organization where your regulatory expertise will help bring innovative hearing solutions to people around the world.

The Team you will be part of:

• You will join a dedicated and experienced Regulatory Affairs team with a commitment to quality, collaboration, and continuous improvement.
• We work closely with colleagues across R&D, Quality, and Commercial functions to enable innovation and compliance throughout the product lifecycle.
• Together, we aim to secure market access, support strategic priorities, and ensure our products continue to meet regulatory requirements in a changing global environment.

Your contribution is appreciated, and you will:

• Support key strategic initiatives within Regulatory Affairs
• Help ensure regulatory compliance for medical devices across global markets, with particular focus on EU and MDSAP markets
• Contribute to regulatory activities across the product lifecycle, including assessments, submissions, registrations, and change management
• Collaborate with cross-functional stakeholders in R&D, Quality, and Commercial teams
• Act as a trusted regulatory partner by translating complex regulatory requirements into clear and practical guidance
• Support internal alignment and decision-making through clear communication and timely stakeholder engagement

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

• Bring solid direct experience from Regulatory Affairs in a global medical device environment.
• It is an advantage if you have experience with hearing healthcare products or other regulated healthcare technologies.
• Have solid knowledge of EU MDR and MDSAP markets, including compliance expectations and regulatory pathways.
• Enjoy combining strategic regulatory work with day-to-day execution and delivery.
• Work well with others and build effective relationships with a broad range of stakeholders.
• Can communicate complex topics in a clear, structured, audience-appropriate way.

We support flexible working whenever possible and trust our people to balance flexibility with the need for in-person collaboration.

We encourage you to apply. Even if you do not match every qualification, we welcome your application if you believe you bring relevant transferable skills.

We value mindset and motivation alongside experience, and we are committed to supporting your growth as well as that of your team and the wider organization.

We are focused on an inclusive recruitment process. All applicants will receive equal consideration for employment.

We encourage you to submit your CV without a photo to support an equal application process.

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

Join us in bringing people closer GN brings people closer through our intelligent hearing, audio, video, and gaming solutions.

Inspired by people and motivated by innovation, we create technology that enhances hearing and sight.

We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and deliver great experiences for audio and gaming users.

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. #LI-Resound

At ReSound, people with hearing loss are at the heart of everything we do because we know they’re placing their trust in us. This is why we haven’t stopped pioneering innovative new technologies, with consistent quality, for over 150 years to help them feel more involved, connected and in control, transforming their lives through the power of sound.

Available exclusively through audiologists and hearing care professionals.

ReSound is part of the GN Group which was founded with a truly innovative and global mindset. Today, we honor that legacy with world-leading expertise in the human ear, sound, wireless technology, miniaturization and collaborations with leading technology partners.

GN's solutions are marketed by the brands ReSound, Beltone, Interton, Jabra and BlueParrott in 100 countries.

Founded in 1869, the GN Group employs more than 6,000 people and is listed on Nasdaq Copenhagen (GN.CO).

If you would like to learn more about our brand, please click on the link to explore our universe of sound.

FEDERAL HEALTH CARE PRICE TRANSPARENCY REQUIREMENTS The Federal Health Care Price Transparency Requirements have created Machine Readable Files to make public the financial arrangements in place between heath plans and providers. These files are designed to be read by a computer and are intended to be available at the industry level for health care researchers, policymakers, analytics companies and applications software to have access to health plan costs nationally on an aggregate basis for the first time. Machine-readable files are a requirement of the Transparency in Coverage Final Rule. Health insurers are required to publicly display certain health care price information via machine-readable files on their websites. GN’s (ReSound, Beltone and Audigy) medical provider, BCBSMN will have “Transparency in Coverage” (TiC) information available. Click here to view BCBSMN TiC’s information on services on how machine readable files will help with the new transparency requirements.

GN ReSound is an Affiantive Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal Employment Opportunity Posters If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email [e-mail]. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail [e-mail]. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.