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:

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

JOB SUMMARY:

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

Your responsibilities will include supporting product development, ensuring regulatory compliance, and staying up-to-date on evolving legislation. If you’re detail-oriented and eager to make an impact in the medical device industry, we’d love to hear from you!

JOB RESPONSIBILITIES:

As a Regulatory Affairs Specialist, your main tasks will include:

Regulatory Knowledge & Compliance

• Monitor and interpret European and national regulations for medical devices;


• Ensure systems are aligned with European regulations (CE marking, safety, MDSAP) and adapt them for non-EMEA markets as needed;


• Provide regulatory updates and recommendations to support business operations.

Standards & Documentation

• Track updates in ISO, EN, and IEC standards and communicate changes to relevant departments;


• Develop and maintain product registration files and assist in preparing technical documentation;


• Liaise with notified bodies and competent authorities during technical document reviews or audits.

Product Labelling & Instructions for Use

• Collaborate with internal teams to ensure multi-lingual product labelling meets European and national regulatory standards.

Project Participation

• Provide Regulatory Affairs (RA) input for local and global development projects;


• Assist in risk management processes, change management, and preparation of clinical, physical, and chemical evaluation reports.

Internal Audits & Post-Market Surveillance

• Conduct internal audits to ensure an effective quality system;


• Support post-market surveillance activities, reviewing data to ensure continued compliance.

General Support

• Provide RA-related information for tender processes and pharmaceutical customer inquiries;


• Maintain and update RA data in global and local database systems;


• Represent Terumo in national and international trade associations, and guide/train new RA team members.

PROFILE DESCRIPTION:

• University degree in a science-related field (preferably medical or pharmaceutical sciences) or equivalent experience;


• 2–3 years of experience in regulatory affairs or quality systems for medical devices;


• Strong knowledge of European medical device regulations (CE marking, ISO, IEC standards);


• Experience developing and maintaining product registration files and technical documentation;


• Proficiency in English (written and spoken), with additional language skills being an advantage;


• Detail-oriented, well-organized, and capable of multitasking in a dynamic environment;


• Excellent communication skills and a team-oriented mindset to collaborate with cross-functional departments.

OFFER:

At Terumo, we believe in offering more than just a job. It's an opportunity to make a difference, contribute to society, and be a part of our passionate and high-performing team.

• Rewards That Match Your Dedication: We offer a competitive salary and benefits package that sets the benchmark for rewarding your commitment;


• Join a Passionate Team: Become a valued member of our passionate and high-performing team where everyone is treated with respect. We are dedicated to creating a diverse, equal, and inclusive work environment;


• Invest in Your Development: At Terumo, we invest in our associates by providing a wide range of development opportunities to help you grow both personally and professionally;


• Work-Life Flexibility: Experience a hybrid way of working that balances office and home-based work to the fullest;


• Connect with Us: During the recruitment process, you'll have the opportunity to engage in meaningful conversations with the hiring manager and other enthusiastic Terumo associates.

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.