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Senior Regulatory Product Compliance Specialist for central position in R&D

Företag GN Group


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Senior Regulatory Product Compliance Specialist for central position in R&D

Join the world’s oldest start-up and turn up the volume on your career

Would you like to step into a central HQ position where you ensure a smooth and efficient market access? And are you motivated by short turn-around times, so that you can actually see that you make a difference for our end users?

Then join us for a unique opportunity to do pioneering work within a well-functioning set-up, where you help us transform lives through the power of sound.

Join a team of ambitious specialists

At GN Hearing, we develop innovative hearing solutions with great sound quality and excellent design to make life sound better for people around the world. Based out of our HQ in Ballerup, you will be joining our Regulatory & Compliance team under our R&D division.

We are 25 skilled professionals and specialists who have a great passion for what we do – overall, we have extremely high ambitions to support the strategic focus on pursuing quality excellence. We do so through working with an array of things – from risk management and usability to engineering processes and post-market surveillance.

How is it to work at GN?

“In GN, our projects have a pretty quick turn-around time, which means that we get to see the impact of our work very early on – giving us a great sense of accomplishment,” says Anita Fjaestad, Regulatory Product Compliance Manager.

Drive and teach efficient Product Regulatory control compliance

As our Senior Product Regulatory 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.

Joining us, you will further get to spend your days:

  • Participate in integrating risk management and usability engineering activities
  • Identify and analyze risks and define mitigations in collaboration with development teams
  • Contributing to the progress of product development projects
  • Support the organization in Design Control compliance
  • Coordinate cross-functional activities to compile and review the Design and Technical files
  • Working with process improvement to create more efficient way of working
  • Carry out in-house training of the organization in design control processes
  • Occasionally traveling to visit global GN offices  

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

  • Problem-solving mindset

You are not afraid of differences in opinion, and you are a great listener, always looking for ways to handle an issue.

  • Ability to prioritize

You master the art of saying “no”, helping you to prioritize all the different requests coming your way. And of course, your “no’s” are well-founded.

  • Experience from working with medical devices

Minimum 3 years of experience from the Medical Device industry combined with some years of experience with Design Control is an advantage.

  • A relevant academic degree

Academical educational degree at Master’s level, preferably in mechanical engineering, chemistry, software or similar. However, relevant professional experience and skills weigh higher.

  • Passion and flair for product development in a regulated industry

Have a 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.

You do not need to have experience with all areas regarding regulatory affairs, design control and risk management.

  • Mindset

An analytical mindset, but at the same time proactive with a high degree of drive, energy and a “can do” attitude with the ability to execute.

Comfortable in a result driven, highly accountable environment where you can make an impact.

Self-driven and a cross-functional mindset

  • Great stakeholder management skills

You thrive with being in charge and setting the agenda, thus being a valuable partner for the organization in all design control-related matters.

  • Fluent written and spoken English skills

As an international organization with colleagues in over 50 different countries, our official company language is English. It’s essential that you can communicate effortlessly with your colleagues, no matter where they are.

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.

Our workplace offers plenty of 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. We hope you are curious to explore and engage in the recruitment process with us.

Think you’ve got what it takes? Apply now

To apply, use the ‘APPLY’ link no later than January 5th 2023. Applications are assessed on a continuous basis, so don’t wait to send yours. 

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

Anita Fjaestad on +45 2788 9649.

We hope you will join us on this journey and good luck with your application.

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Senior Regulatory Product Compliance Specialist for central position in R&D

GN Group