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.
Apply Now
Don't forget to mention EuroPharmaJobs when applying.