510(k) Senior Regulatory Compliance Specialist to GN Hearing

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

Join us at GN Hearing – part of the GN Group – we bring people closer
At GN we design and manufacture world-leading intelligent audio, video, and gaming communication solutions. We have consumer, professional and medical-grade products and expertise, all under one roof.

Inspired by people and driven by our passion for innovation, we leverage technologies to deliver unique user experiences that bring people closer through the power of sound.

Welcome to the Regulatory Compliance team in the R&D division at GN Hearing
At GN Hearing, we are dedicated to developing innovative hearing solutions with great sound quality and excellent design that enhances the quality of life for people enabling people with hearing loss to hear more, do more and be more.

Stepping into the role as Senior Regulatory Product Compliance at Corporate Quality, you will join over 25 skilled professionals in driving efficient Regulatory Compliance. Located at GN’s HQ in Ballerup, Denmark, you will report directly to our Regulatory Product Compliance Manager, Sarah Søgaard-Hansen.

What will you be doing?
As our 510(k) Senior Regulatory Compliance Specialist, you will be supporting the projects in the R&D organization on everything regarding Regulatory Affairs and Design Control.

In this role, you will especially focus on 510(k) submissions to the FDA playing a critical part in ensuring the success of these submissions which are vital to our product development and market access efforts.

Expect to spend your day on tasks like:

• Support in developing a regulatory strategy that meets FDS requirements and maximizes the chances of clearance.
• Preparing required 510(k) documentation and complete 510(k) submissions to the FDA
• Providing guidance on preparing and submitting pre-submission documents and scheduling meetings, responding to requests for additional information, and managing other interactions with the FDA.
• Carrying out in-house training of the organization in 510(k) submissions

• Contributing to the progress of larger product development projects incl. planning, writing, and delivering technical documentation (incl. peer reviews) as well as 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.
• SME Monitoring of Directive, Regulations & Standards

Sound good so far? Here’s what you’ll need to succeed and create results

• A relevant academic degree
• Solid experience from the Medical Device industry, preferably combined with experience in Regulatory Affairs and/or Design Control.
• Experience with the 510(k)submission process (incl. e-copy/eStar). Preferably with worked with similar devices before.
• Good communication skills to communicate effectively with the FDA and rest of the development team. It is essential that you can interpret guidances and communicate them to the team clearly and concisely.
• Deep understanding of device classification within the medical device industry and be well-versed in associated regulatory requirements. This knowledge is essential in determining the appropriate type of 510(k) submission for our products.
• In-depth knowledge and understanding of medical device standards, guidelines and regulations e.g., MDR, FDA 21 CFR Part 820, 807 and 860, ISO 13485, ISO 14971, IEC 62366-1, IEC 62304 etc.

• Analytical with strong problem-solving skills and a high degree of drive
• Attention to detail with the ability to prioritize.
• Stakeholder management skills and team player mindset

The GN culture
GN’s values listen, challenge, and transform form our culture. We greet every day with energy, engagement, and enthusiasm, bringing our best selves and approaching problem-solving and challenges with a ‘glass half full’ attitude. We’re independent, but we also know when two heads are better than one. Our leaders are supportive, our teams are tight-knit, and we believe in the power of collaboration across every level of our organization.

What we offer you
While making a big difference for all our customers, we also believe in creating a fantastic and flexible work environment. We want everyone to contribute with their ideas and improvements that can benefit our products or the way we do things. Our workplace offers different benefits and flexibility to keep us happy and healthy and allow us to focus on what matters to us in and outside of work.

Think you’ve got what it takes? Apply now
To apply, use the ‘APPLY’ link no later than December 15th, 2023. We do encourage you to send your application already now.

Quick apply
You are welcome to use our Quick Apply function, where you only submit your CV. We only ask that your CV is up to date – quick and easy.

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

We hope you are curious to explore and engage in the recruitment process with us and wish you good luck with your application.

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Location: Ballerup