Senior Specialist, Regulatory Affairs to GN Hearing

Posted 14 Days Ago
Be an Early Applicant
Hiring Remotely in Ballerup, Hovedstaden, DNK
Remote
Senior level
Healthtech • Retail • Wearables • Manufacturing
The Role
Support strategic regulatory initiatives and ensure global regulatory compliance for hearing medical devices (focus EU and MDSAP). Manage assessments, submissions, registrations, and change control across the product lifecycle. Collaborate with R&D, Quality, and Commercial teams, translate regulatory requirements into actionable guidance, and support stakeholder decision-making and internal alignment.
Summary Generated by Built In

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.

How to apply?

Use the ‘APPLY’ link no later than September 27th, 2026. Applications are assessed continuously, so don’t wait to send yours.

Feel free to only submit your up-to-date CV, including a few sentences outlining your motivation for applying – quick and easy.

We will close and unpublish the position once we have identified the candidate to hire, this might be before the above-mentioned date.

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

Skills Required

  • Direct experience in Regulatory Affairs within a global medical device environment
  • Knowledge of EU MDR and MDSAP markets, compliance expectations and regulatory pathways
  • Experience supporting assessments, submissions, registrations, and change management across product lifecycle
  • Ability to translate complex regulatory requirements into clear, practical guidance
  • Strong collaboration and stakeholder engagement skills with R&D, Quality, and Commercial functions
  • Experience with hearing healthcare products or other regulated healthcare technologies
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The Company
7,455 Employees
Year Founded: 1869

What We Do

ReSound, part of the GN Group, is a global leader in intelligent audio solutions and a pioneer in the hearing aid industry. They specialize in developing innovative digital hearing aids and wireless accessories designed to help people with hearing loss rediscover hearing and live active, fulfilling lives. By combining audiology expertise with deep research and development, they provide personalized sound experiences in over 80 countries.

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