(Senior) Regulatory Product Compliance Specialist to Corporate Quality, Group R&D

Would you like to step into position where you ensure a smooth and efficient market access, making a difference for our end users?

At GN, we develop innovative hearing solutions with great sound quality and excellent design to ensure that hearing aid users will be able to hear more, do more, and be more. In the role as (Senior) Regulatory Product Compliance Specialist you will contribute to our purpose of Bringing People Closer.

Welcome to the Regulatory & Compliance team in the R&D division at GN
Stepping into the Regulatory Compliance team in the Corporate Quality department, you will join over 25 skilled professionals in driving efficient Regulatory Product Compliance. Located at GN’s HQ in Ballerup, Denmark, you will report directly to our Regulatory Product Compliance Manager, Sarah Søgaard-Hansen.

As our Regulatory Product Compliance Specialist, you will be supporting the projects in the R&D organization on everything regarding Regulatory and Design Control. A significant part of your role will be to take part in planning and implementing the required documentation, including regulatory, usability engineering and risk management, in compliance with current regulatory standards for medical device development.

Your contribution is appreciated, and you can expend to spend your day on tasks like:

• Participating in integrating risk management and usability engineering activities
• Identifying and analyzing risks and defining mitigations, in collaboration with development teams
• Plan, write and deliver technical documentation
• Contributing to the progress of product development projects
• Supporting the organization in design control compliance
• Coordinating cross-functional activities to compile and review the Design and Technical files
• Working with process improvement to create more efficient ways of working
• Carrying out in-house training of the organization in design control processes

To succeed in the role, we imagine that you bring:

• A relevant academic degree
• Some experience from the Medical Device industry, preferably combined with experience in design control and/or regulatory affairs. You do not need to have experience with all areas regarding regulatory affairs, design control and risk management.
• Good understanding of medical device standards, guidelines and regulations e.g., ISO 13485, ISO 14971, MDR, IEC 62366-1, IEC 62304 and possibly with FDA requirements for the development of medical devices and design control.
• An interest in product development in a regulated industry
• Analytical and problem-solving mindset
• Ability to prioritize
• A high degree of drive
• Stakeholder management skills

Even if you don’t match all the above-mentioned skills, we gladly receive your application if you think you have transferrable skills. We highly value the right mindset; motivation and energy and we believe that the right personal competencies are highly important for creating success.

We are dedicated to an inclusive recruitment process and all applicants will receive equal consideration for employment.

Join us in bringing people closer
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.

How to apply?
To apply, use the ‘APPLY’ link no later than May 6th, 2024 Applications are assessed on a continuous basis, so don’t wait to send yours.

You are welcome to use our Quick Apply function, where you only submit your up-to-date CV, including a few sentences outlining you motivation for applying – quick and easy.

We encourage you to submit your CV without a photo to ensure an equal and fair application process.

If you would like to know more about the position, please contact Regulatory Product Compliance Manager, Sarah Søgaard-Hansen,

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

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Location: Ballerup