![Terumo Europe](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Administrator
il y a 3 semaines
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.
**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.
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.
**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**.
Terumo offers an **attractive salary and benefits package**. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike (in Belgium).
We offer an opportunity to work in a top performing team. An organisation where everyone is treated with **respect**. We strive to create a **diverse, equal and inclusive work** **environment**. We invest in our associates by offering a broad array of **development opportunities.**
Linked with our core value **Care**, Terumo allows a hybrid way of working, combining office with home-based work.
During your recruitment process, you’ll be able to have conversations with Sophie Rooms as the hiring manager and other passionate Terumo associates.
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**:
Jarne Jans - Talent Acquisition Partner
- 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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