Regulatory Affairs Manager
Regulatory & Quality Affairs
- Joined the altona Diagnostics team as ninth in 2009
- Ensures worldwide approval of our products
- Founder of the R&D Verification team
- Her children have also had a taste of altona air
My professional path
After completing my biology studies in Osnabrück in 2003, I went to Hamburg to do my doctorate at the Bernhard Nocht Institute for Tropical Medicine. With my doctorate in hand, I got an internship at altona in 2009 and just 4 months later a permanent position. At that time I was employee No. 9, today we have over 350 employees.
After starting out as a product developer, I was put in charge of the R&D verification group. From 2017 I helped set up the Regulatory Affairs unit.
My tasks as Regulatory Affairs Manager
“I can always rely on my altona colleagues.”
My current work and that of my regulatory affairs colleagues can be divided into 3 areas. Firstly, we create the technical documentation for each altona IVD product and keep it up to date. For example, the technical documentation must be adapted whenever there is a product change.
Secondly, we ensure that our products are approved in accordance with standards and laws in all countries in which they are to be sold.
Thirdly, we document all approvals in our enterprise resource planning system and in this way ensure that orders can only be created for countries in which an approval exists.
My professional highlights
Over time, I was able to play a key role in shaping two areas. On the one hand the R&D verification group, on the other hand the Regulatory Affairs unit created in 2017.
A milestone as Regulatory Affairs Manager was the establishment of a system for creating electronic backups of the technical documentation for the entire altona Diagnostics product portfolio.
That’s why I like working at altona
Since I started in 2009, I have been able to adjust my weekly working hours to my family situation several times, e. g. after the birth of my two children. The flexibility and accommodating attitude of all those responsible have been very helpful in this.
Not a matter of course either: I can always rely on my altona colleagues, both professionally and personally.
And that’s also possible
The altona summer festival 2022 at the Fischauktionshalle in Hamburg-Altona was a highlight, especially for my two children. The afternoon program was specially tailored to the altona children. They got to know each other with foosball, goal wall shooting, air hockey, crêpes and fish sandwiches and had a lot of fun.
The altona Girls’ and Boys’ Day was also great for my two children. Here the two were able to get a first-hand look at their mother's company.