Regulatory Affairs Expert
il y a 1 semaine
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 an experienced professional in regulatory affairs looking to make an impact in the medical device industry? Terumo is seeking a Regulatory Affairs Expert to join our EMEA team in Leuven, Belgium. Reporting to the Regulatory Affairs Manager, you will be part of a team of five, providing regulatory services to ensure compliance and product approvals across Europe, the Middle East, and Africa. This role involves mínimal supervision and will require you to take the lead in key regulatory processes, including product development and post-market surveillance.
As a Regulatory Affairs Expert, you will manage regulatory documentation, ensure compliance with evolving regulations, and act as a representative in product-related projects. You will also guide and support other team members, ensuring that the highest regulatory standards are met. If you are ready to take on a leadership role in a collaborative environment, we encourage you to apply
**Responsibilities**:
**Regulatory Knowledge & Compliance**:
- Stay up to date with new developments in European medical device regulations and monitor relevant national regulations across EMEA.
- Maintain and update regulatory systems to comply with European regulations (e.g., CE marking) and MDSAP requirements.
- Implement or modify systems to meet regulatory needs outside the EMEA region when required.
- Provide regulatory guidance to local offices and internal teams on evolving legislation.
**ISO, EN, and IEC Standards Compliance**:
- Follow and monitor progress in medical device standardization efforts.
- Communicate updates to relevant departments to ensure compliance with international standards.
**Technical Documentation & Product Registration Files**:
- Develop and maintain product registration files and technical documentation for Terumo-manufactured products.
- Lead and manage the review of technical documentation with Notified Bodies and Competent Authorities.
- Ensure all product information, including brochures and leaflets, aligns with technical documentation and regulatory requirements.
**Labelling & Instructions for Use Compliance**:
- Ensure that Terumo’s multilingual product labels and instructions for use meet European and national regulatory requirements. Work closely with internal departments and Terumo affiliates to maintain accuracy.
**Project Involvement**:
- Provide regulatory input for global and local product development projects, ensuring all applicable regulations and standards are followed.
- Support the preparation and review of material specifications, clinical evaluations, and risk management reports.
**Internal Audits**:
- Participate in internal audits as needed to maintain an effective quality system audit program within Terumo Europe.
**Post-Market Surveillance**:
- Assist in the analysis and review of post-market surveillance (PMS) data to ensure continuous regulatory compliance and product safety.
**General Support**:
- Provide regulatory input for tender processes and ensure accurate data management within regulatory systems.
- Supervise and maintain Master Data (item code creation) as required.
- Act as a liaison with national regulatory officials, under the guidance of the Regulatory Affairs Manager.
- Lead or participate in assigned projects, assist with training and guidance for new regulatory team members, and represent Terumo in national or international trade association groups.
**Profile Description**:
- University degree in a scientific field, preferably in medical or pharmaceutical sciences.
- At least 5 years of experience in the medical device or pharmaceutical sector, with a strong focus on regulatory affairs.
- Strong understanding of European medical device regulations (CE marking, MDSAP) and ISO, EN, and IEC standards.
- Experience with product registration, technical documentation, and liaising with regulatory authorities.
- Excellent command of English (written and spoken); additional language skills are a plus.
- Detail-oriented, well-organized, and capable of managing multiple projects simultaneously.
- Strong communication skills and a collaborative mindset to work effectively with cross-functional teams.
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