Regulatory Device Scientist
il y a 3 semaines
**Make your mark for patients**
We are looking for a **Medical Device Regulatory Scientist** to join us in our **Regulatory Affairs** team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK), Atlanta/Raleigh (US) or Toronto (Canada) offices.
The Medical Device Regulatory Scientist is responsible for regulatory activities for marketed and development medical devices and combinations products within the scope of the Neurology, Immunology, and New Medicines units.
As a **Medical Device Regulatory Scientist,** you will have the following responsibilities:
- In alignment with the global regulatory strategy, responsible for strategy, planning, definition of content, preparation, review, and approval of global submissions for device constituents of combination products in assigned projects/products to achieve timely approvals to meet business needs.
- Accountable for preparing and maintaining DEVICES Technical Documentation Files aimed to obtain CE Marks, NBs Opinions and / or FDA clearance on assigned projects.
- Interacts with HAs/NBs
- Supports the global CMC regulatory strategy for assigned projects/products is consistent with the GRA Practice, S&TS Teams, and Patient Solutions Team (PST) missions, goals, and objectives.
- Identifies supporting DEVICES documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Ensures Life Cycle Management support (i.e., Changes/Deviations/improvements) to maintain regulatory compliance of approved DEVICES
Interested? For this position you’ll need the following **education**, **experience** and **skills**:
- Bachelor’s degree
- Knowledge in drugs/medical devices manufacturing processes
- Knowledge of GMP/ISO requirements and standard systems (e.g. change management systems and tools)
- Knowledge of IVD, MDR, 510K, IMDRF requirements
- Demonstrated competence in contributing on cross-functional teams and operating within a matrix organizational structure.
- Ability to input medical devices expertise into the global regulatory strategy and global planning, to indemnify the critical issues and share lessons.
- Ability to synthetize technical information and data to author medical devices technical documentation, CTD Module 3 and briefing books to be submitted to Health Authorities and Notified Bodies
- Knowledge of drug delivery products (syringes, inhalers, patches, pumps).
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
**Learn more** about sustainability at UCB and how it is integrated into our business approach.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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