Senior Regulatory Affairs Manager (m/f/x)

Full timefull-time, München/Munich
Temedica https://temedica.com/en/
Being part of Temedica means you are part of something that helps people! It means you get the opportunity to craft the future of personal health and, at the same time: your future! We strive to improve patients' Quality of Life and accompany them along their therapy journey - by providing health companions that are fully tailored to every patient's personal needs.

At Temedica, we combine digital technologies with medical science - two areas that for us are inseparable.

We believe in ambitious, open-minded people like you - eager to change an industry that is just at the beginning of essential changes. Join us on our journey and become part of our team in the heart of Munich!

As Regulatory Affairs Manager at Temedica, you ensure our medical digital products are developed and approved according to applicable standards. You support our agile development teams and ensure that the necessary documentation for product approval is created.

What you will be doing

  • You oversee all regulatory processes for the approval of our innovative digital products in Germany and prospectively worldwide
  • You are open to new approaches from agile software development and support our teams with advice and actions during the certification process
  • You work in a team in the area of Regulatory and Quality and continuously develop your subject areas further
  • You create the relevant documentation for certification together with the product teams
  • You are the interface between the notified bodies and Temedica and accompany all certification steps across the Temedica product family

What you will bring to the table

  • 3+ years of experience in regulatory affairs for medical devices.
  • Extensive knowledge in relevant legislation and standards (MDR, ZPP, ISO 13485, IEC 62304, DVG, GDPR etc.)
  • Enjoy challenging and adapting your previous understanding of regulatory affairs in the context of agile methods
  • A strong communication talent that you use to inspire other colleagues about regulatory topics
  • You love to develop and implement processes and structures
  • You have a very good command of German and English

Don't apply if

  • You want to implement regulatory affairs processes from the corporate environment in a startup
  • Don't enjoy dealing with other people who, in case of doubt, have never worked in a regulated environment before
  • Always want to have everything done 100% correctly

What we offer you

Aside from the people, the role, our culture, and our mission, we have countless other things, that make Temedica a pretty great place to work at:
  • We are an open-minded and international team that loves to collaborate to reach our goals
  • We live a professional feedback culture with regular objective performance reviews and room to grow
  • We invest in your personal and professional growth: let's define together your goals and find pieces of training that fit into your development plan
  • We equip you with state-of-the-art technology (e.g., MacBook Pro) and offer you a workplace where you feel comfortable - right in the city center of Munich
  • We give you the chance to play a decisive role in shaping Temedica, directly impacting the health of thousands of patients
  • We enjoy spending quality time together such as Go Kart, Octoberfest or sports activities
  • We are a market-proven, well-funded and fast-growing company
  • We offer you relocation and visa support
Are you looking for an exciting challenge? Come and join - we are looking forward to receiving your application!
 
In addition to your CV, start date, and salary expectation, please tell us a bit about why you are interested in joining Temedica, how an ideal role for you should be shaped for you. Thank you!
Paul-Heyse-Str. 27 Munich 80336 Bayern DE Date Posted:

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Benefits at Temedica

Trust

We believe in you. That's why we give you maximum responsibility and trust from day one.

Feedback

We think it is essential to engage in lively dialog and give feedback based on a culture of fairness.

Goals

We work determinedly toward achieving our goals, and we embody our common values.

 

Team Events

Here you“ll get fantastic coffee, snacks and, of course, a great place to work.