Quality & Regulatory Affairs Manager (w/m/d) - Vollzeit
We’re a team of 23 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?
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.
- Degree preferentially in engineering, (medical) technology, life sciences or comparable qualifications
- Experience in the application of the MDR/MDD and corresponding norms and standards (i.e. ISO 13485, IEC 62304, ISO 14971, IEC 62366) preferable
- Experience with Software as a Medical Device (SaMD) preferable
- 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
- Excellent communication skills 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
- 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
- In your position, you combine agile software development and regulatory affairs.
- 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 developers 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.
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!