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Regulatory Affairs Administrator

Posted On:  25-Jul-2021
Job Category:  Other

At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates.

 

Department Info


Terumo Regulatory & Vigilance Division operating from Leuven (Belgium) provides supporting services in regulatory affairs and post market surveillance to Terumo internal and external customers on an EMEA basis.

 

Job Summary


As a Regulatory Affairs (RA) administrator, within Regulatory & Vigilance department, you’ll be responsible for providing administrative and technical support related to the daily activities of your supervisor, as well as managers, experts, specialists and officers. 

 

Job Responsibilities

 

As our RA Administrator, you’ll work with the different regulations that are applicable on the medical devices that Terumo produces. This will allow you to take over daily activities from RA experts, specialists and offices, when needed. Additionally, you’ll come in contact with the ISO, EN and IEC standards that are related to our products. You’ll have to find certain standards in the NBN online library and support both the technical and sales departments, when they put in requests regarding certain standards. 

 

You possess the needed product knowledge, so that you can prepare both routine and more complex registration files. You’ll provide assistance in sending out and following up of notifications concerning changes. You’ll also be required to provide support regarding the applications of documents and certificates, that are needed for registrations. In addition, you’ll maintain the registration database, follow up on registration approvals and share all relevant information with the related departments.  

 

You’ll perform tasks related to the labelling requirements & instructions for medical devices. Therefore, you’ll need to be knowledgeable in that area of expertise as well. You’ll provide support during the translations and evaluation processes of the labels. Additionally, you’ll act as a Masterfile coordinator. Consequently, you’ll maintain the electronic documentation system and you apply organisational changes to the related documents. You’ll also be the one to keep record of all the external documents. 

 

By fulfilling your role as RA administrator, you’ll assist in the handling of customer product complaints. Those complaints can be related to the products specifically, but also to the sales process. In addition, you’ll provide administrative support in preparing, issuing and the follow-up of FSCA’s (Field Safety Corrective Actions. You’ll also be required to support the approval of return orders.

 

One of your core responsibilities is the maintenance of the RA information in the diverse information systems. Additionally, you’ll contribute to the applications of documents and other types of applications. 

 

Profile Description

 

You possess a scientific bachelor’s degree and an additional interest in administrative tasks or an experience in administrative support for Regulatory Affairs. 

 

Possessing knowledge and experience concerning regulations and quality systems for medical devices, will be regarded as an additional advantage. 

 

We’re also open to people with a background as a lab assistant/lab technician or an education related to those domains. 

 

You are fluent in English. This is related to both the written and verbal skills. A proficiency in other languages will be regarded as an advantage. 

 

You are familiar with Microsoft Office and you are open to learn to work with new software programs. In addition, you are accurate, organized and a team player. 
 

Offer

 

Working for Terumo means contributing to society through healthcare. We offer a full-time employment contract accompanied by an attractive salary package. 

 

We offer a fantastic opportunity to work in a top performing team. A work environment in which every associate, customer and business partner is treated with respect, where sincerity is key and where everyone always strives to find the most optimal solution. Furthermore, you’ll find yourself in an environment that promotes a mindset that embraces challenge for the future. 

 

Interested to contribute to the growth of Terumo? Interested to find out more? Take a look at Terumo Europe's Corporate Video or at our website !

 

Contact Person

 

Bethsabee Bellinck.

 

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.

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