Senior Regulatory Manager (m/f/x)

Full timefull-time, München/Munich
Temedica https://temedica.com/en/ Jobs
We are a Digital Health Startup in the heart of Munich. Our mission is to improve the quality of life of our users. With our mobile apps we accompany patients on their individual health path and help them to achieve the best possible therapy results.

What you will be doing

  • Translate regulatory landscape to product specific action plans (e.g. MDR IIa, FDA 21 CFR 820)
  • Evaluate product specific risk management
  • Contribute all regulatory aspects to technical documentation (jointly with QM)
  • Manage certification process
  • Oversee/ do post-market surveillance

What you will bring to the table

  • Minimum bachelor degree in science or engineering
  • > 5 years of regulatory experience in the medical device industry, preferably with medical software
  • Comprehensive regulatory knowledge, e.g. guidelines, policies, applicable product laws/standards
  • Strong project management experience, especially with supporting new product developments and launches
  • Fluency in English and German

The ideal candidate

We are looking for a Senior Regulatory Manager who wants to make a difference.

What we can offer

With our digital products, we accompany patients on their individual path to personal health and help them to achieve the best possible therapy results. Health and well-being is also very important to us for our employees.
  • We are an open, motivated and international team
  • We believe in you - you get maximum responsibility and trust from day one
  • We practice a fair feedback culture so that everyone can fully exploit their potential
  • We are working goal driven and live our shared values
  • We organize regular team events, provide you with delicious coffee, snacks and smoothies and have a really cozy office
Join us on our mission and become part of Temedica!
You are looking for an exciting challenge and you bring the necessary experience with you? We look forward to receiving your application. In addition to your CV, please let us know what your motivation for the position is and what your expectations are.
Paul-Heyse-Str. 27 Munich 80336 Bayern DE Date Posted:

Apply now

Please fill in this field.
Please fill in this field.
Please fill in this field.
Please enter a valid email address.
Please fill in this field.
Powered by Personio  |  personio.de

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.