Medical Device RA/QA Project Associate in München bei Medidee

Looking for an exciting job with Medidee in Bavaria?
Medical Device Quality Assurance, Regulatory and Clinical Affairs
Project Associate – Munich Area

In-Vitro Diagnostics compliance with international regulatory requirements.

We serve clients with hands on help and support for compliance with applicable regulatory requirements
of our clients’ target markets. Our services cover all steps of Medical Device and IVD development, from
the initial project idea, design and development, through to clinical validation, regulatory clearance and
post market surveillance activities.
Based in Switzerland, Germany, Belgium, Denmark and the United States, we are active for clients world-
wide.

We are looking for qualified individuals for serving our clients. Applicants should be fluent in German
and English (other languages are a plus). Your mission will be to provide the following consulting services
to our clients:

§ Working on medical device projects with tight certification / submission deadlines in close coop-
eration with the client and in compliance with the new EU Medical Device Regulation (MDR
2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746), as well as US 21 CFR Part 800
Regulations.

§ Implementing Quality Management Systems (QMS) in compliance with ISO 13485, US 21 CFR
Part 820 (GMP), as well as Medical Device Single Audit Program (MDSAP).

Delivering on-site and remote consulting services including quality management and regulatory affairs.

Working with us
Be part of a small but fast-growing group within Medidee where individual skills matter! Autonomous,
self-starter and able to adapt quickly will be required to address a wide variety of projects and
customers. Excellence and and attention to detail are important aspects achieving regulatory
compliance.

We offer projects involving cutting-edge innovation in MedTech industry that will require quick learning
of technical and medical concepts in order to best guide our clients. Your colleagues are other QM, RA
and Scientific experts, and opportunities are provided to share experiences and competences. Traveling
is also part of the fun! We are looking for individuals with:

§ A master degree (or equivalent) in life sciences or in a technical field such as Mechanics, Elec-
tronics, Engineering, Chemicals, Software, or other subject matter expertise relevant to medical
devices or IVD development.

§ Experience working independently, setting own agenda and objectives

§ Eager to learn and able to learn quickly

§ Strong German & English writing skills; ability to communicate complex technical and medical
concepts.

Interested?
Send an email including a CV and a short bio to moritz.hoyer@medidee.com




2020-09-10 Project Associate - Bavaria.doc