Our RAO keeps customers safe
By Marc Martens
The government imposes regulations on certain things - foods, medicines, chemicals etc. - in order to protect the public. Being a packaging supplier to the pharmaceutical and food industry, CurTec needs to keep up to date with these regulations in order to remain compliant and stay in business. To ensure compliance and continue to provide High Performance Packaging to their customers, CurTec hired a Regulatory Affairs Officer (RAO).
A company’s ability to successfully operate within the regulated environment imposed by the government, hinges on being able to properly understand those rules and regulations. An RAO combines its scientific, legal, and business knowledge, to ensure products are compliant with the appropriate regulations and that a company is operating within the law.
CurTec’s RAO, Eef van Holland, embodies Regulatory Affairs and explains why it is an interesting and important job: “CurTec has a well-organized quality assurance system. Over the years, they have spent a lot of time and money on quality management, not only to meet legal requirements of the UN, FDA and EU (regarding hazmat shipment or food safety), but also to live up to customer demands. The pharmaceutical and chemical industry often ask for proof of quality and compliance.
“Answering customer questions regarding compliance and completing quality questionnaires is only part of my job. I also liaise with governments and other regulatory bodies to keep an eye on regulatory landscape changes and fuel our quality care program. The requirements of our target markets have gratefully contributed to the way our quality management is organized today.” CurTec has recently become a GMP certified production facility, thanks to the pharmaceutical industry.
Eef has a bachelor degree in Industrial Design and a background in Research & Development. She has had additional training studying Quality and Change Management. She also has a master degree in Business Management, which is not a prerequisite for her job, but helps her to understand business operations: “My job requires tapping into most departments at CurTec, especially when Change Control Projects are concerned. These projects are complex and require input from both external and internal sources. Understanding peoples functions and responsibilities helps me to acquire and provide the right information.”
Her position involves a lot of paperwork, careful reading, and ticking boxes, but as she says: “The bottom line is keeping people safe, and that is something I feel good about.”