Quality and Regulatory Affairs Manager

Senior Quality and Regulatory Affairs Manager

Permanent contract
Remote, office located in Berlin, Germany - Must travel on-site once a month
Up to €80 000

Are you an experienced QA Manager with experience in regulatory affairs and ISO?

Do you enjoy working in med-tech?

Then this position is made for you!

5V Tech is proud to be working in partnership with a company in Berlin, who are at the forefront of innovative fem-tech. They are a passionate team of visionaries and engineers looking to revolutionise med-tech, in particular linked to women health.

Though this position is remote, you will have to be able to travel to the Berlin office once a month, and therefore be in the EU area.

Duties:
- Take care of the implementation and maintenance of a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)
- Ensure that the processes and products meet all necessary quality and regulatory requirements before they reach the users
- (In English, though it could also be in German) Communicate with Notified Body and other responsible authorities
- Ensure documentation is always kept up-to-date

Requirements:
- Proven experience with managing QM systems in accordance with ISO related to med-tech such as 13485, ISO 14971 (or ISO 9001) and FDA
- Experience with regulatory affairs for medical devices and QMS
- Knowledge of, or experience with, in-vitro diagnostic medical devices regulation (MDD / MDR) IVDR and CFR
- Exceptional communication skills, attention to detail and project management experience or knowledge

Nice to have:
- Experience in med-tech / fem-tech
- Able to speak German to B1/B2 level
- Start-up mindset

Apply now to get full details!

5V Tech are acting as an Employment Agency for the purposes of this job vacancy. We offer a reward scheme if you can recommend someone for this position, up to £250 for you and an additional £250 to a charity of your choice, 5V Tech are recognised talent solutions experts within IoT and Deep Tech working across Europe, the UK and North America.