Regulatory Product Compliance Specialist to Corporate Quality

Ensure efficient Market Access
Would you like to play a key role in ensuring smooth and efficient market access for innovative hearing solutions?

At GN, we empower people to hear more, do more, and be more. As a Regulatory Product Compliance Specialist, you’ll help us bring people closer through advanced Over-The-Counter (OTC) hearing technologies.

The team you will be part of:
You’ll join the OTC part of Regulatory Operations (RO) team within Corporate Quality, working alongside skilled professionals. In this position, you’ll assist with OTC 510 (K) and various other significant initiatives, ensuring adherence to global medical device regulations and supporting the development of OTC products.

Your contribution is appreciated, and you will:

• Identify and analyze risks, define mitigations in collaboration with development teams
• Plan, write, and deliver technical documentation- required 510(k) documentation and support 510 (k) submissions to the FDA
• Support design control compliance across the organization
• Coordinate cross-functional activities to compile and review Design and Technical Files
• Facilitate process improvement initiatives for more efficient ways of working

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

• A relevant academic degree- electrical or software engineering or similar
• Experience in the medical device industry, with exposure to design control and regulatory affairs
• Familiarity with standards and regulations such as ISO 13485, ISO 14971, MDR, IEC 62366-1, IEC 62304, FDA 21 CFR Part 820 and 860 and FDA design control requirements
• Experience from development of software driven electronic products
• Familiarity with Cybersecurity risks and guidance documents
• Experience with regulatory submissions
• QMS experience
• A keen interest in product development in a regulated environment
• Proficient analytical, prioritization, and stakeholder management skills
• A forward-thinking approach and aspiration to enhance effectiveness
• Any experience with 510(K) or other regulatory submissions

We encourage you to apply
Don’t meet every requirement? We still encourage you to apply—your mindset, motivation, and engagement matter the most. 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?
Apply by clicking the ‘APPLY’ link no later than August 30th, 2025. Applications are reviewed on a rolling basis, so don’t wait to submit yours.

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

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.

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

#LI-GNGroup
Location: Ballerup