Trainee - Quality & Regulatory Affairs (f/m/d) - Full-time
About us
We’re a team of 24 people developing Software as a Medical Device (SaMD) for customers in the area of medicine and healthcare. With clinics and MedTech companies, we push the status quo of the health space forward. We develop apps where quality craftsmanship is needed: Doctors, patients, and managers rely on our apps to be regulatory compliant and work flawlessly under any circumstances.
Who are we searching for?
Patients and doctors want medical devices that are safe to use and achieve a medical purpose. And regulatory authorities want us to be able to prove that.
As a Trainee in Quality & Regulatory Affairs (f/m/d), you will learn how to achieve that goal and what is necessary to being able to put the famous CE-mark on a product.
We are looking for a talent with an affinity for processes, software products and regulatory requirements in the field of (Software) Medical Devices, who wants to contribute to shaping the healthcare industry of tomorrow.
If you are dedicated to push projects forward and bring regulatory compliant apps to the market, we have something in common. As part of the Quality & Regulatory Affairs team, you will work in many projects with different approaches. That’s how we ensure a steep learning curve to make you an expert for Regulatory and Quality Management topics. You will get in touch with a lot of people in the industry and help them to combine Regulatory Affairs and agile Software Development.
You are also going to be involved in a constantly growing field: DiGA. More and more of our clients need support with that brand-new concept in the German healthcare system. We’ll teach you what’s necessary to become an expert in this area.
About you
- Current or finished study preferentially in engineering, (medical) technology, information management, life sciences or comparable field
- Strong interest or even basic knowledge of Quality Management, ISO/IEC standards and medical device regulations
- A digital mindset and a keen interest in new technologies and software
- Structured way of thinking with an eye for details
- Hands-on mentality, strong analysis and documentation skills, good teamwork and a cross-functional environment
- Fluent in German and English
- High independence and hands-on mentality
- Ability to proactively push the team to comply to regulatory
- Pragmatic mindset to implement regulatory requirements in a practical and efficient way
Your responsibilities
- You work closely with the management- and project- team to ensure the delivery of regulatory compliant products (including the creation, submission and maintenance of the necessary regulatory documents)
- You take ownership in implementing new regulatory requirements in our Quality Management System
- You consult our clients in all aspects of regulatory compliance and DiGA requirements
- You evaluate and improve our existing processes and documents
- You support the team with internal audits
What we offer
- No monotony. You will always work on different products, with different people & approaches
- You will gather a lot of experience (also in the field of DiGA)
- You will work in a young and international team of people that share a passion for medical apps
- Your personal and professional growth is crucial to us. We provide learning budget, mentorship, training and many other things to help you thrive
- Opportunity to make an impact: work on health projects that change people’s lives for the better
- Personal mentor and environment to help you learn fast
- Lots of team events like hiking, go-carting, beer garden evenings, sledging, hackathons, etc.
- Office at the heart of Munich at Stiglmaierplatz
- Ability to work from home or remotely
- We value work-life-balance and if you really decide to work more, you’ll get paid for that (or get additional holidays)
- Full relocation support if you are coming from abroad (help with Visa, getting a flat, finding new friends etc.)
Application
Tell us what drives you, which topics you’re excited about and what you worked on before. Put your standard application letter aside. Instead, let us know what makes you jump out of bed in the morning. That’s more interesting for us than your university grades.
You want to work with people you like, that push you forward and inspire you? Same for us. We want to get to know you as a person and can’t wait to get in touch with you!
