Regulatory Affairs Specialist

Terumo Europe

Leuven, Belgium

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.

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