Technical Lead - Regulatory Product Surveillance Professional

In this position, you will serve as the technical lead for GN's Regulatory Product Surveillance team. Your primary task will involve the device investigation process, which includes the hands-on examination of the devices themselves. Following your investigations, you will offer crucial insights for new product development, design, risk management, among others.

The team you will be part of:

Regulatory Product Surveillance team is a group of 7 colleagues’ in Corporate Quality (CQ), located at GN's Headquarters in Ballerup, Denmark. The Regulatory Product Surveillance team and our ability to bring important insights into our product quality and development are highly appreciated across GN. We learn and reinvent together as a team, with our focus being on advancing post-market surveillance activities. Our diversity of thought, personality and background is our superpower.

We encourage professional development, both by learning and knowledge sharing on the job and also across Regulatory Operations, Corporate Quality and the wider organization.

Your contribution is appreciated, and you will:

• Act as the technical lead for GN's Regulatory Product Surveillance team
• Manage the device investigation process including hands-on examination of devices
• Provide vital insights for new product development, design, and risk management, among other areas
• Maintain and improve our current device investigation protocols
• Facilitate and support other post-market surveillance activities, including trend reporting, field actions/recalls, CAPA/NC, customer complaint resolution, incident reporting, audits and PMS insights
• Planning, reporting, and documentation in collaboration with stakeholders throughout R&D and GN worldwide.
• Mentor Student Assistants in on our team

To succeed and make it happen, we imagine that you bring:

• An Engineering or other Technical degree
• Curiosity in and knowledge of medical devices, regulatory environment, quality systems, risk management and vigilance
• Knowledge of standards like ISO 13485, ISO 14971, MDR
• Experience working with Power BI or other smart solutions
• Experience with scientific writing and audit/inspections
• Experience working with Customer Feedback or Vigilance related to Medical Devices
• A curious and engaging positive attitude

We encourage you to apply
Even if you don’t match all the above-mentioned skills, we will gladly receive your application if you think you have transferrable skills. We highly value a mindset, motivation, and energy, that aligns with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well.

We are committed to 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 upon accepting invitation to interview.

How to apply?
Use the ‘APPLY’ link no later than September 25th. Applications are assessed on a continuous basis, so don’t wait to send 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.

If you would like to know more about the position, please contact Jana Ritslev, Manager, Regulatory Product Surveillance on [email protected]

Join us in bringing people closer
GN brings people closer through our leading 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 challenges, improve communication and collaboration for businesses and provide great experiences for audio and gaming enthusiast.

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

#LI-GNGroup

Location: Ballerup