Quality & Regulatory Affairs Manager (w/m/d) - Vollzeit

About us

We’re a team of 25 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?

We are looking for a Quality & Regulatory Affairs Manager (f/m/d) 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 a Regulatory Affairs Manager you will work in many projects with different approaches. That’s how we ensure a steep learning curve to make you our internal 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

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

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

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.

Application

Interested? Shoot us an email!

[email protected]

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!

More about us

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