Ballerup, Capital Region of Denmark, Denmark · Hybrid
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 regula…
Skills: Regulatory Affairs, Medical Devices, EU MDR, MDSAP, Regulatory Compliance
Shakopee, Minnesota, United States · On-site
Position Overview This position assembles and inspects medical devices using work instructions and Standard Operating Procedures (SOP’s). Assemblers will regularly work with microscopes, hand tools, and/or small componen…
Skills: Assembly, Manufacturing, Quality Control, Hand Tools, Power Tools
Helsinki, Uusimaa, Finland · Hybrid
The purpose of this position is to deliver a high-quality customer experience to GN Hearing customers in Finland supporting our organizational goal to provide reliable service in the industry. We are looking for a Custom…
Skills: Customer service, Order processing, Invoicing, Communication, Problem solving
Ballerup, Capital Region of Denmark, Denmark · On-site
The purpose of this position is to deliver a high-quality customer experience to GN Hearing customers in Ballerup supporting our organizational goal to provide reliable service in the industry. We are looking for a Custo…
Skills: Order processing, Navision ERP, Salesforce CRM, Customer service, Invoicing
Shakopee, Minnesota, United States · On-site
$30/hr–$33/hr
Position Overview The Manufacturing Engineering Technician is responsible for all production and calibration equipment used within production operations. Key responsibilities include calibrations, preventive maintenance,…
Skills: Manufacturing engineering, Equipment calibration, Preventive maintenance, Troubleshooting, Root cause analysis
Shakopee, Minnesota, United States · Remote OK
Position Overview To provide audiological and technical support to customers through hearing aid fitting assistance and providing product information and troubleshooting assistance for current and discontinued product li…
Skills: Audiology, Hearing aid fitting, Technical support, Troubleshooting, Software platforms
Lowell, Massachusetts, United States · On-site
$105k–$110k/yr
Position Overview The Field Training Audiologist will contribute to sales and profitability by providing product and software training designed to increase customer knowledge, skills and familiarity with the ReSound prod…
Skills: Audiological Fitting, Product Training, Adult Learning Principles, Public Speaking, Workshop Facilitation
Ballerup, Capital Region of Denmark, Denmark · Hybrid
Help bring better hearing to people worldwide by coordinating product registration compliance and documentation for our hearing aids and accessories across 90+ markets. And would you like to develop your skills in a glob…
Skills: Compliance, Documentation, Product registration, Administrative support, Customer contact
Ballerup, Capital Region of Denmark, Denmark · Hybrid
As a Senior QA Developer, you will take on a key role in optimizing and evolving our testing area and process. We are looking for someone who takes initiative, works proactively and plans ahead — someone who can drive te…
Skills: Software testing, Test automation, C#, Embedded software, Firmware testing
Shakopee, Minnesota, United States · Hybrid
$22/hr–$25/hr
Position Overview The Customer Service Representative serves as a primary point of contact for customers, providing exceptional service and support related to GN ReSound hearing solutions. This role is responsible for re…
Skills: Customer Service, Technical Troubleshooting, Communication, Problem Solving, Order Processing
Ballerup, Capital Region of Denmark, Denmark · Hybrid
In the role as a Student Assistant, you will support several teams across the Regulatory Operations area and learn a wide variety of skills, while contributing to our purpose of Bringing People Closer. If you are up for …
Skills: Regulatory Documentation, Data Management, Data Analysis, Process Improvement, Programming
Ballerup, Capital Region of Denmark, Denmark · Hybrid
We are looking for a specialist with broad FEM experience for our mechanical development department in GN Hearing. The Team you will be part of: Welcome to GN Hearing’s Mechanical line of R&D. With a team of more than 20…
Skills: FEM, 3DXperience, Python, Material Modelling, Structural Mechanics
Navi Mumbai, Maharashtra, India · On-site
In the role as Key Account Manager, you will contribute to our purpose of Bringing People Closer. You will be responsible for expanding, strengthening, and optimizing the dealer network across the region. The role will f…
Skills: Dealer Network Expansion, Relationship Management, Sales Growth, Market Penetration, Channel Development
Ballerup, Capital Region of Denmark, Denmark · Hybrid
As Regulatory & Lifecycle Compliance Specialist in GN Hearing, you will contribute to our purpose of Bringing People Closer, by helping ensure that our hearing aid products remain compliant throughout their lifecycle. Yo…
Skills: Regulatory Compliance, Medical Device Regulation, Product Lifecycle Management, Risk-Based Approach, Technical Documentation
Sydney, New South Wales, Australia · On-site
THE OPPORTUNITY At GN Hearing we are united in our ambition to bring people closer through the power of sound. Our hearing solutions combine cutting-edge technology with deep audiological expertise to help people hear mo…
Skills: Audiology, Clinical Training, Relationship Building, Problem Solving, Communication
Sydney, New South Wales, Australia · Hybrid
At GN Hearing we are united in our ambition to bring people closer through the power of sound. Our hearing solutions combine cutting-edge technology with deep audiological expertise to help people hear more, do more, and…
Skills: Audiology, Product Training, Technical Support, Presentation Skills, Microsoft Office
Shakopee, Minnesota, United States · On-site
$21/hr–$25/hr
Position Overview This position works in the Inventory area in Materials Management. You will be receiving, sorting, and stocking incoming product. You will be shipping bulk products to internal & external customers and …
Skills: Inventory Management, Shipping and Receiving, Dangerous Goods Processing, Export Documentation, Cycle Counting
Shakopee, Minnesota, United States · Hybrid
$115k–$125k/yr
ABOUT THE COMPANY GN is a global leader in communications and bringing people closer together. Founded in Denmark more than 150 years ago the company currently operates 3 complementary divisions: Hearing, Enterprise, and…
Skills: Agency Management, Program Management, B2B Marketing, B2B2C Marketing, Leadership
Ballerup, Capital Region of Denmark, Denmark · On-site
Do you want to be part of redefining the future of training at GN, making it the best of its kind in the industry? At GN Hearing, we are bringing people closer – we do so through the newest technology so that our hearing…
Skills: Audiology, Instructional Design, Learning Science, Curriculum Design, Project Management
Shakopee, Minnesota, United States · On-site
$18/hr–$21/hr
Position Summary This role is responsible for the precise assembly, wiring, and inspection of medical devices (hearing aids) following strict work instructions and Standard Operating Procedures (SOPs). The Assembler will…
Skills: Precision Assembly, Soldering, Microscope Proficiency, Quality Control, Electro-acoustic Testing
Ballerup, Capital Region of Denmark, Denmark • Hybrid
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You will support strategic regulatory initiatives and ensure ongoing compliance for medical devices across global markets. This involves collaborating with cross-functional teams to manage product lifecycle activities, including submissions, registrations, and regulatory assessments.
The role requires solid experience in regulatory affairs within a global medical device environment. Candidates must possess strong knowledge of EU MDR and MDSAP regulatory pathways and demonstrate the ability to communicate complex requirements effectively.
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.
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.
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
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.
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.
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.
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.
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.
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Part of GN- Bringing People Closer
ReSound is part of GN Group, the global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. We place people with hearing loss at the heart of everything we do. Our aim is to bring people closer to their loved ones and to the things they love to do through intelligent audio, visual and medical hearing solutions.
Offices: Lautrupbjerg 7, Ballerup, 2750, DK · 5005 Dean Lakes Blvd, Shakopee, Minnesota 55379, US · 2 East Beaver Creek Rd., Building 3, Richmond Hill, Ontario L4B 2N3, CA · GN ReSound Building A, Kirtlington Business Centre, Portway, Kirtlington, Oxfordshire OX5 3JA, GB · Office No.1201/1202/1203, 12th Floor, V Times Square, Plot # 3, Sector # 15, Palm Beach Road, CBD Belapur, Navi Mumbai 400614, IN
Part of GN- Bringing People Closer
ReSound is part of GN Group, the global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. We place people with hearing loss at the heart of everything we do. Our aim is to bring people closer to their loved ones and to the things they love to do through intelligent audio, visual and medical hearing solutions.
Offices: Lautrupbjerg 7, Ballerup, 2750, DK · 5005 Dean Lakes Blvd, Shakopee, Minnesota 55379, US · 2 East Beaver Creek Rd., Building 3, Richmond Hill, Ontario L4B 2N3, CA · GN ReSound Building A, Kirtlington Business Centre, Portway, Kirtlington, Oxfordshire OX5 3JA, GB · Office No.1201/1202/1203, 12th Floor, V Times Square, Plot # 3, Sector # 15, Palm Beach Road, CBD Belapur, Navi Mumbai 400614, IN
