Regulatory Affairs Officer

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. 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.

Applications for this position, will be processed in the beginning of September.