Dr. Silvia Kluge, Team Leader in Regulatory Affairs
Follow your interests
A passion for biology and purpose
A student’s life
A deep dive into the industry
A member of the team
Silvia began working in Regulatory Affairs in 2020. As she points out, it’s a diverse field – and regulations are crucial to ensure products are safe and effective. She oversees, among others, aspects of product life cycle management, and change control management; first and foremost from the perspective of regulatory compliance in Wound Care. As a Team Leader, Silvia draws on her past experiences where she learned the value of a team that works together. She explains, “I’m one of the team and when we are in a tight spot, we work side by side and do what needs to be done. I really appreciate that we can debate with each other and stand up for each other.”
What does she enjoy most about her job? “The detective work. Working with people who can use structured thinking to take apart processes, put things in a logical order, and defend solutions.” Looking at the product pipeline and seeing that legislation is a constantly evolving field, in which new regulations, directives and guidance documents are constantly arising, the team will have no shortage of challenges in the future!
Silvia says she’s had good role models in the past and particularly at HARTMANN and appreciates how much teamwork is supported here. She explains, “HARTMANN’s Fit to Lead program allowed me to learn so much about Leadership, about working with different personality types and bringing out their potential.” HARTMANN’s program also gave her additional training to become a certified ‘RA Manager International’.
A part of HARTMANN
Silvia remembers the first time she walked through the doors of HARTMANN, “Everyone said ‘Good Morning’ or ‘Hello’ regardless of whether they knew each other.” After several years at HARTMANN, Silvia has a continued sense that the company is really made up of its employees – it’s more than a logo. “HARTMANN is us,” she says. And in her job in Regulatory Affairs, she’s found the purpose she envisioned for herself when she first started out – a job that helps people.