Ra Officer

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**:
**Job Summary**:
Terumo Quality Systems and Regulatory Affairs department operating from Haasrode, Belgium, provides supporting services in quality systems and regulatory affairs to Terumo internal and external customers on a European basis.

As part of this department, the main responsibility of the RA Officer is to take care of services in regulations, registrations, technical files and standards, and to assist in the complaint handling for devices related to a particular business unit.

**Responsibilities**:

- 1.
- **Regulations.**
- Closely follow and monitor new tendencies in European regulations for medical devices and laboratory equipment.
- Closely monitor legal and regulatory issues related to medical devices on national level (EEA and Eastern Europe)
- Maintain the current systems implemented for medical devices and laboratory equipment to comply with European regulations (CE marking, safety,...)
- Assist in the implementation of new systems or amend existing systems to be able to comply with the regulation in main countries outside Europe (e.g. US, Canada, Australia ), whenever required to support the business.
- Assist RA Manager in providing support to local offices on regulatory issues.
- 2.
- ** ISO, EN and IEC standards.**
- Closely follow and monitor the progress in standardisation work applicable to the medical devices and labo equipment.
- Communicate to the related departments (TES, TEST, ME,)
- 3.
- **Product registration files / technical files.**
- Product knowledge
- Develop and maintain product registration files, design examination files for medical devices and laboratory equipment
- Develop, prepare and maintain the technical files for medical devices manufactured by Terumo Europe

4. **Requirements for labelling & instructions for use**
- Assist to ensure compliance of the multi-lingual packaging and instruction for use of the Terumo products, with European and national regulations in co-operation with involved TE departments, TC, TMC, TCVS, TMPH, TCP and local Terumo Europe representatives
- 5.
- **Internal audits.**
- Assist as auditor to perform internal audits for maintaining an effective quality system audit programme within Terumo Europe
- 6.
- **Complaint handling**
- Assist in the complaint handling for products related to a particular business unit.
- 7.
- ** General**
- Support tender business

**Profile Description**:

- University degree in sciences the preference medical / pharmaceutical oriented or equivalent education, experience in scientific environment (clinical research, biochemistry ).
- Experience in regulations and quality systems for medical devices is not required, but are an asset.
- Good working knowledge of English (written and spoken). Other languages can be an advantage.
- Accurate, self-disciplined & well organized, good at multitasking, excellent communication skills as will work closely with other dept., team player.

**Offer**:
We offer you an exciting position as an RA Officer in an international medical devices company.

You'll join a passionate RA team, with team members who will guide you to further develop your skills.

We offer an environment that values quality products and care for patients and health care professionals at its heart, together with a competitive salary and benefit package.

Interested to find out more? Take a look at Terumo Europe's Corporate Video or at our website

**Contact Person**:
Peter Coolen

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._