Regulatory Affairs Officer

Terumo Europe NV; Leuven; On-site; EUR 55,000 - 75,000; Full time

Job summary

Terumo Europe NV in Leuven, Belgium, seeks a Regulatory Affairs Officer to ensure medical devices meet European, Middle Eastern and African regulatory requirements. The role reports to the Regulatory Affairs Director and involves managing product registrations, labeling reviews, and staying updated on regulatory changes across EMEA.

The candidate should have a science degree, strong English skills, and the ability to collaborate across departments.

Qualifications

• Experience or knowledge of regulatory requirements for medical devices and pharmaceuticals is an asset.
• Excellent written and spoken English.
• Dutch language knowledge is an advantage.
• Accurate, organized, and able to multitask in a cross-functional team.

Responsibilities

• Prepare and maintain product registration files.
• Review labelling and promotional material for regulatory compliance.
• Ensure multilingual product labeling and instructions comply with regulations.
• Monitor regulatory developments across EMEA and support new systems implementations.
• Provide regulatory information for tender processes and customer inquiries.

Skills

Regulatory affairs

English proficiency

Communication skills

Multitasking

Education

Science degree

Job description

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.