Company : Terumo Location : Leuven Flanders From : Talent BE
The Regulatory Department is located in our HQ in Leuven, Belgium.
For this position we are looking for a Belgium based candidate that is legally entitled to work in Belgium and than can assure weekly presence in the office.
Job ResponsibilitiesDatabase System Implementation:
Together with the RA Manager you will set-up and manage a robust database system in alignment with the MDR EUDAMED regulations and requirements.
Regulatory Monitoring:
the RA team closely monitors legal and regulatory requirements related to medical devices at the national level.
We pay specific attention to regulatory database systems in the EU, USA, and MENA regions.
Procedural Enhancement:
We’ll actively contribute to implementing new procedures and systems or modifying existing ones.
Our goal is to ensure compliance with national regulations and those specifically related to the introduction of regulatory databases.
Collaboration and Alignment:
you will coordinate with our external service provider to facilitate seamless data exchange.
Additionally, we’ll align our workflows within Terumo Europe to maintain accurate and up-to-date databases.
Centralized Data Management:
You will follow-up that new or updated information is uploaded promptly by the responsible product owners, creating and maintaining a centralized source of truth for critical data sets.
Product Documentation Support:
As a bridge between our business and external manufacturers, you will assist in product registration files and technical documentation for products manufactured by Terumo Europe.
Risk Management and Evaluation:
Our team will actively engage in risk management, clinical evaluation, and post-market surveillance alongside the review of physical, chemical, and biocompatibility reports.
Alignment with Technical Documentation:
You review product information to ensure it aligns with the technical documentation.
Regulatory Input in Product Development:
You will support in the provision of regulatory affairs input on applicable regulations and standardization during product development and change control processes for Terumo Europe-manufactured products.
Quality Assurance Audits:
You will support internal audits to maintain an effective quality system audit program within Terumo Europe.
This ensures compliance with European regulations and MDSAP requirements.
Profile DescriptionA Master degree in sciences (preferably medical / pharmaceutical oriented) Knowledge of ISO, EN, IEC standardsExperience in regulatory affairs in life sciences industryExperience with database management in a related industry will be considered a strong assetGood working knowledge of English (written and spoken); other languages are advantageousAccurate, self-disciplined, well-organized, and adept at multitaskingExcellent communication skills for collaboration within the team and across other departmentsExperience with or interest in project management OfferWorking for Terumo means contributing to society through healthcare.
We offer an opportunity to work in a top performing team.
An organisation where everyone is treated with respect.
We strive to create a diverse, equal and inclusive work environment.
We invest in our associates by offering a broad array of development opportunities.
Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work.
For the Regulatory Affairs team a regular presence in the office close to the manufacturing plant, combined with work at home is the guideline.
Terumo offers an attractive salary and benefits package.
Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike and we offer 12 additional holidays on annual basis. Terumo LeuvenFlanders
