Regulatory Affairs Officer

Terumo Europe NV; Vlaams-Brabant; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Benefits package

International environment

Career development support

Zusammenfassung

Terumo Europe NV in Leuven, Belgium, is seeking a Regulatory Affairs Officer to ensure medical devices meet EU/MEA requirements. You will support product registrations, review labeling, and help maintain CE marking compliance under the guidance of the Regulatory Affairs Director.

We value detail-oriented professionals with a scientific background, fluent English, and teamwork across functions. Dutch knowledge is an advantage; Belgian commute to Leuven is expected.

Qualifikationen

• University degree in science or equivalent experience in a scientific environment.
• Experience in regulatory affairs is an asset but not required.
• Strong multitasking and communication skills in a regulatory team.

Aufgaben

• Prepare and maintain product registration files for Terumo Europe products.
• Review labeling and promotional material for regulatory compliance and accuracy.
• Monitor European regulatory developments and ensure CE marking compliance.
• Support tender-related regulatory information and provide local office guidance.

Kenntnisse

English (Fluent)

Dutch (advantage)

Regulatory knowledge

Scientific background

Ausbildung

Science degree

Jobbeschreibung

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for

Job description

Department Info

Terumo Quality, Regulatory & Vigilance Department, operating from Leuven, Belgium, provides regulatory affairs and post-market surveillance support to Terumo’s internal and external customers across EMEA.

Job Summary

Are you passionate about healthcare and regulatory compliance? Join Terumo as a Regulatory Affairs Officer, where you will play a key role in ensuring our medical devices meet European, Middle Eastern and African regulatory requirements. Reporting to the Regulatory Affairs Director, you will be part of a close-knit team working together to navigate complex regulatory landscapes and maintain product approvals.

Your responsibilities will include supporting regulatory services for product registration and reviewing labelling and promotional material to ensure the accuracy of product information and alignment with applicable legislation and standards.

If you are detail-oriented and eager to make an impact in the medical device industry, we would love to hear from you.

Job Responsibilities

Prepare and maintain product registration files.

• Develop, maintain and supervise product registration files for products manufactured and/or sold by Terumo Europe.

Review labelling and promotional material.

• Ensure that multilingual product labelling and instructions for use for Terumo products comply with European and national regulations, in cooperation with the relevant Terumo Europe departments and Terumo affiliates.
• Review product information (brochures, leaflets, website) to ensure it is not in conflict with information available in the technical documentation.

Build knowledge of regulations.

• Closely follow and monitor new developments in European medical device regulations.
• Closely monitor legal and regulatory issues related to medical devices at national level across EMEA.
• Maintain the systems implemented for medical devices in compliance with European regulations, including CE marking and safety requirements, and with MDSAP requirements where applicable.
• Assist in implementing new systems or amending existing systems to comply with regulations outside EMEA and in MDSAP countries whenever required to support the business.
• Provide support to local offices on regulatory issues.

Enable the business.

• Support tender-related activities: Provide regulatory affairs information for tender processes and customer enquiries.

Profile

• A university degree in science, preferably with a medical or pharmaceutical focus, or an equivalent qualification and experience in a scientific environment such as clinical research or biochemistry.
• Experience in regulatory affairs in the medical device and/or pharmaceutical field is not required but is an asset.
• Good working knowledge of English, both written and spoken. Knowledge of Dutch is an advantage.
• Accurate, self-disciplined and well organised, with strong multitasking and communication skills and the ability to collaborate effectively within the department and across functions.
• You live in Belgium and can commute easily to the office in Leuven.

Offer

You will join an international Regulatory Affairs environment where you will play an active role in monitoring regulatory developments, driving their implementation and helping to ensure compliance across the organisation.

You will join a passionate Regulatory Affairs team whose members will support you as you further develop your skills.

We offer an environment that puts quality products and care for patients and healthcare professionals at its heart, together with a competitive salary and benefits package.