Quality Management & Regulatory Affairs Intern

**Internship: Quality Management \& Regulatory Affairs** -------------------------------------------------------- **The Challenge** ----------------- We are currently evolving the way we manage quality and safety for our **EU MDR Class IIa medical device**. As we scale, we are transitioning our entire Quality Management System (QMS) and Technical Documentation into a new, state-of-the-art software environment. We are looking for a motivated Master's student (or recent graduate) to support the **refactoring of our risk management** and help us build a more agile, software-driven compliance framework. ### **Your Responsibilities** * **Risk Management Refactoring:** Analyze and restructure existing risk management files (ISO 14971\) to ensure they are robust, scalable, and fully compliant with ISO 13485, ISO 14971, EU MDR and FDA requirements. * **Digital Transformation:** Support the transfer of Technical Documentation and QMS structures from Gitlab into our new software tool Matrix Requirements. * **Process Engineering:** You will design, develop, and implement improved QMS processes that make life easier for our engineering and customer facing teams. * **Knowledge Transfer:** You will be the 'power user' of the new system. This includes creating documentation and conducting training sessions to ensure the team is up to speed. ### **Your Profile** * **Education:** You are currently enrolled in or have recently completed a **Master of Science (M.Sc.)** in Biomedical Engineering, Regulatory Affairs, Life Sciences, Health Sciences or a related technical field. * **Regulatory Interest:** You are interested in understanding the regulatory landscape of a medical device company under **ISO 13485** and **ISO 14971**. * **Analytical Mindset:** You enjoy 'untangling' complex systems and turning them into clean, logical structures. * **Communicator:** You can translate complex regulatory requirements into clear instructions for others. * **Tech-Savvy:** You are comfortable working with eQuality Management System or Application Lifecycle Management software tools and have an interest in digital compliance. ### **What We Offer** * **Real Impact:** You will be responsible for core components of a Class IIa medical device's compliance strategy. * **Flexibility:** We offer **flexible work hours** to accommodate your studies or personal schedule. * **Dynamic Culture:** Join a young, driven team that moves fast and values new ideas. * **Career Growth:** Deep-dive into QMS process development and risk management – core skills in the MedTech industry. **Timeframe:** 6\+ months. We're looking for someone to grow with us through this transition.