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Regulatory Affairs Specialist

il y a 1 mois

Leuven, Belgique Terumo Europe Temps plein

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

**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.

**Contact Person**:
**Jarne Jans** - Your dedicated Talent Acquisition Business Partner for EMEA