Global Market Access Regulatory Specialist

In the role as Global Market Access Regulatory Specialist in the Market Access Team, based in the Corporate Quality department, you will contribute to our purpose of Bringing People Closer. Our core responsibility is to support and ensure world-wide Medical Device Product Registrations approvals, to be able to launch our products to the markets. Your daily work involves cooperation with different stakeholders internally as well as externally. The team you will be part of: You will be welcomed into a skilled team that includes 6 team members and 1 student worker at our headquarters in Ballerup, Denmark, we also have 1 team member in Kazakhstan and 3 team members in China. We have a great team culture of supporting each other whenever needed. In the team everyone has specific areas of responsibilities, with possibilities for development. It is very important for our team to also have fun in our daily work. Your contribution is appreciated, and you will be: Responsible for product registration cases world-wide for Medical Devices class I and IIa Responsible for submission of technical file documentation for tenders and re-imbursement approval processes Responsible for answering questions from Authorities in relation to the technical file documentation Responsible for specific markets as Market Access SME Responsible for collecting & developing technical file documentation Responsible for ordering legalization of documents and Free Sales Certificates Contribute to developing & maintaining Market Access processes, work instructions & templates Contribute to PI planning every quarter Contribute to audits To perform well in the role, we imagine that you: Have a relevant master’s or a bachelor’s degree within e.g. Medical Market Access Have experience with world-wide Medical Device product registration approval processes Have knowledge of EU MDR, ISO 13485 and other medical device standards and regulations Have good stakeholder management skills Have great collaboration and communication skills and you thrive in working in an international environment Have attention to details and deadlines Demonstrate high-level of English skills, oral and written It is beneficial to have experience with Medical Device submissions and communication to authorities It is beneficial to have experience with project management We encourage you to apply Even if you don’t match all the above-mentioned skills, we welcome your application if you think you have transferrable skills. We highly value a mindset and motivation that align with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well. 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. How to apply? Use the ‘APPLY’ link no later than September 15th, 2026. Applications are assessed on a continuous basis, so do not 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. The position will be closed once the preferred candidate has been identified. This might be before the above mentioned date. 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 enhance the senses of hearing and sight. We enable people with hearing loss 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. #LI-GNGroup 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.