Regulatory Operations Life Cycle Management Specialist

at  GN Group

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

• 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 skill