Regulatory Operations Life Cycle Management Specialist
1 month ago
Are you absolutely mad about Regulatory Life Cycle Management and would like to step into a central HQ position where you as part of the Regulatory LCM team ensure a smooth and efficient market access? We are looking for a Regulatory Operations Life Cycle Management Specialist to join us for a unique opportunity to do innovative work, where you enable us transform lives through the power of sound.
The team you will be part of
At GN Hearing, we develop innovative hearing solutions with great sound quality and comprehensive design to make life sound better for people around the world. Based out of our HQ in Ballerup, you will be joining our Regulatory Operations team under our RDC division.
You will work with over 25 skilled colleagues with great enthusiasm for what we do – overall, we have extremely high aspirations to support the strategic focus on pursuing high quality standards. You will report to Life Cycle Management Manager, Camilla Krogsgaard, but your daily work will be with your internal and external stakeholders.
Your contribution is appreciated, and you will:
As our new Regulatory Operations LCM Specialist, you will join a newly established team of 3 specialists. You will be supporting the projects in the R&D organization on everything regarding Regulatory Life Cycle Management.
A significant part of your role will be to take part in regulatory assessment of in-market changes and updating required documentation including risk management in compliance with current regulatory standards for medical devices.
Besides working with in-market change management, you will also be involved in:
Strategic and regulatory projects
Audit
CAPA
Regulatory intelligence monitoring
To succeed in the role, we imagine that you:
Have a relevant academic degree
Have experience in the Medical Device industry, along with knowledge in design control, risk management, as well as regulatory affairs. You do not need to have experience with all areas regarding regulatory affairs, design control and risk management.
Have an interest in life cycle management in a regulated industry
Embrace a mindset geared towards effective solution-finding
Have the ability to prioritize
Have a high degree of motivation
Have advanced stakeholder management skills
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 06 September 2024. 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.
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 enthusiast.
We hope you will join us on this journey and look forward to receiving your application.
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