Expert for the approval of medical devices | Kristin Ratschiller

Responsible for the approvals of new devices, keeping the quality management up-to-date, supporting internal and external audits, developing QM systems, anchoring the European legal framework – it never gets boring in Regulatory Affairs (QMS+RA). 

Kristin Ratschiller, Team Leader QMS+RA maintains an overview of the diverse tasks. “The nice thing about Regulatory Affairs is that we support a product over its entire lifecycle: From the development to the approval process, right up to aftercare / lifecycle management. As a result of this, we have many interfaces and work together in cross-functional teams”, explains Kristin.

“I have come to stay.”

Kristin has already been part of the Weinmann Community since 2012. However, Kristin's path to WEINMANN Emergency was anything other than planned: “At some point, I saw the job advertisement and then simply applied just for fun”, she says. Prior to that, Kristin worked in a group of companies, in which production and administration worked separately from one another. “I wanted to see the big picture, so I intended to go back to a medium-sized enterprise. At WEINMANN Emergency, I had the feeling that all of the departments work very closely together with one another. This feeling has confirmed itself in recent years.” She recalls a sentence from her interview to this day: “I have come to stay.” With her 10-year anniversary, she is well on her way.

Opportunity to become a team leader

A particular highlight of Kristin’s time at WEINMANN Emergency was the opportunity to become a Team Leader. “In 2016, I became the Team Leader and accepted the switch from being a colleague to a Team Leader with lots of zeal. My colleagues supported my decision. This is naturally a very good feeling, when your colleagues wish to have you as a Team Leader”, says Kristin. At the moment, her team is comprised of eight people: “We all have different personalities, but that’s exactly what I like so much about my team. We complement each other well and everyone stands up for one another.”

Mutual respect between the colleagues

Kristin particularly likes how WEINMANN Emergency handles the error culture: “We all deal with errors openly. We are only human and no one does everything perfectly all of the time. It is only important that we learn from our errors.” This open error culture leads to mutual respect and appreciation between the colleagues. “This team spirit doesn’t stop in the department, but also transcends all departments.” Kristin is especially impressed by the commitment to cooperation partners, who had to flee Ukraine this year: “It was immediately clear that WEIMANN Emergency would give its employees a leave of absence, so that they could bring our partners to Germany. At the same time, colleagues furnished apartments and organized excursions so that everyone would feel welcome. The focus is definitely on people.”

Challenges of the MDR for the QM system

It never gets boring in QMS+RA: “We are living in challenging regulatory times. Previously, the rules of the game were clearly defined, but in recent years, the MDR has implemented new requirements, which we now gradually need to deal with. That makes it all the better, when we notice that our working method is going in the right direction”, says Kristin. She was able to prove that in 2020, when the MDR process audit was around the corner: “We passed the audit without any discrepancies. Once again, this showed that: We made the right decisions. Not only us in the team, but also the entire company”, Kristin summarizes.