Regulatory Affairs Officer

Datum: 28-sep-2022

Plaats: België

Bedrijf: terumoeuro

Bij Terumo verbeteren we levensreddende medische technologieën voor onze samenleving. 
Gretig om ook bij te dragen aan de gezondheid van mensen en het welzijn van patiënten? We dagen je uit om een meester te worden in jouw vakgebied. Investeer je talenten in balans met je persoonlijke ambities. Leven en werken in harmonie. 
Vanuit onze Japanse oorsprong, worden we gedreven door respect, eigenaarschap en voortdurende verbetering. 
Het is de kern van alles wat we doen. Zo maken we een verschil in het leven van patiënten, klanten en medewerkers.

Department Info

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

Job Summary

As a Regulatory Affairs (RA) Officer, within our Regulatory & Vigilance department, you’ll be responsible for granting and maintaining product approvals. In addition, you’ll be required to remain updated on the applicable legislations and standardizations, to provide the required RA expertise in development processes. Thereby, you’ll contribute directly to assuring regulatory correctness of the information that is supplied with our products.

Job Responsibilities

As our RA Officer, you’ll need to provide up-to-date RA expertise. Therefore, you’ll need to closely monitor new tendencies in the European regulations for medical devices, in vitro diagnostics and laboratory equipment. In addition, you’ll need to monitor legal and regulatory related issues, as well as progression in standardisation work, in correlation to said products. All findings, insights and relevant news needs to be communicated to the relevant departments.

You’ll contribute to maintaining the implemented systems for our products, to ensure compliance with European regulations and you’ll provide assistance in the implementation of new systems and the amendment of existing systems. 

By fulfilling your role, you’ll assist the RA Manager and other RA members in providing support to local offices on regulatory issues

You remain up-to-date on all product knowledge. This knowledge allows you to develop and maintain product registration files with the particular national requirements, as well as technical files. In addition, you’ll contribute to the development, maintenance and review of design examination files. You’ll also review product information (e.g. brochures, leaflets) to assure that the provided information is not in conflict with the information that is available in technical or registration files. 

You’ll contribute to ensuring compliance of the multi-lingual labelling and instruction of use with European and national legislations, concerning all Terumo Products. Consequently, you’ll cooperate closely with other departments, business units and Terumo Europe representatives. 

As an RA officer, you’ll be a part of development projects. You’ll provide RA input on applicable regulations and standardisation in product development processes, assist in risk management processes and provide the necessary support for the preparation of clinical evidence.

You’ll also fulfil an Ad Hoc role as an auditor in the execution of internal audits. Thereby, you’ll contribute to maintaining an effective quality system audit programme within Terumo Europe. In addition, you’ll contribute to the post market surveillance by assisting in the preparation of Vigilance Reports and FSCA.

Profile Description

You have obtained a university degree with a scientific orientation (preferably medical or pharmaceutical). An equivalent education and/or experience within a scientific environment will also qualify.  

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

You are fluent in English. This entails both the written and spoken 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. 

You posses strong communication and organizational skills. In addition, you are accurate, self-disciplined, proficient in multitasking and a real team player.

Offer

Working for Terumo means contributing to society through healthcare. 

Terumo offers an attractive salary and benefits package. 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. For the this role this means approximately 50% in the office, 50% at home, ensuring team connection face to face in the office on a fixed working day. During your recruitment process, you’ll be able to have conversations with Valérie Boydens 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

Bethsabee Bellinck. 

Talent Acquisition Partner - Terumo Europe. 

Due to holiday period, applications will be handled as of September. 

Terumo Europe is een belangrijke speler in de EMEA healthcare markt. We maken deel uit van Terumo Corporation (Japan) en produceren, verdelen & verkopen medisch materiaal. Het EMEA hoofdkwartier en productiefaciliteiten van Terumo Europe zijn gevestigd in Leuven (België). Onze saleskantoren zijn verspreid over de EMEA regio.