Meet the Team

Name: Bettina

Position: Head of Quality and Regulatory Affairs

Team: Quality and Regulatory Affairs

How long have you been with Belfry? I have been part of the Belfry team for more than 2 years.

What's your professional background? I studied Biology at the University of Bonn. After finishing my PhD I started to work in the Regulatory Affairs Departement of a pharmaceutical company manufacturing medicinal products from human blood. I became the Head of the Regulatory Department being responsible for the national and international product registration of coagulation factors, the lifecycle-management of about 420 registrations in Europe and the selection and implementation of a document management system. After leaving this company (after 20 years), I used my knowledge as a scientific employee at the DGRA (Deutsche Gesellschaft for Regulatory Affairs). There I gained a deeper insight into the field of medical devices which fascinated me with its broad product variability. At this point I switched to the medical device sector by joining a start-up company which develops implants for joints. There I have built up the Quality Management System from zero until certification and was also responsible for the compilation and submission of the technical files. The submissions led to company and product certifications within a very short time. Belfry is now my second start-up to work with .

Personal Background:

I was born in Düsseldorf, moved to Bonn for my studies, came back to Düsseldorf for work and settled in Neuss, on the other side of the Rhine opposite to Düsseldorf, in a smaller and greener area for my kids.

I have been married for more than 30 years (being together already 10 years before we married this sums up to more than 40 years now) and together we have two adult daughters. In 1998, I was the first woman in my company having an innovative model for organizing child-care: In the even weeks I was working full-time in the office and my husband (working in another company using the same model) stayed at home all day (cooking for the kids, participating in the toddler groups etc.) and in the uneven weeks my husband worked full-time in the office and I stayed at home with the kids.

Fun fact: Writing my diploma-thesis in 1988 I was the first one in the whole institute who used a computer (including a 5 1/4 inch floppy disc) and MS Word instead of a type writer.

Responsibilities within Belfry:

I have two major responsibilities: Firstly I am responsible for the creation, certification and maintenance of the Belfry QMS. My second responsibility is the regulatory part. Before and after the certification of a Medical device many regulatory requirements for development, production, market launch and monitoring must be fulfilled. This includes:

• defining regulatory strategies,
• compiling regulatory submissions.
• being the contact person for the notified body and other authorities.
• ensuring post-market surveillance.

The most interesting part in the filed of Quality assurance is, in my opinion, building up a QMS from zero. You can set it up according to your experience and ideas instead of working within an already established system. Furthermore, I like the special, motivated atmosphere and spirit in a small team working hard for the first product certification.

The most challenging aspect of my work is the regulatory part for our product, which includes different hardware as well as software components. So a lot of regulations are applicable to the several parts of our product.

Fun Things to know about me:

What's your favorite vacation destination? I would love to go to the antarctica with an expedition sea voyage to see this fascinating landscape and wildlife, especially the penguins.

Share one of your favorite quotes or mantras. You should take things as they come but you should make sure that they come the way you want to take them.