Medical Device Regulatory Scientist

il y a 6 jours

Anderlecht, Belgique UCB Temps plein

**Make your mark for patients**

We are looking for a **Medical Device Regulatory Scientist** to join us in our **Global** **Regulatory Affairs** team, to be based in our Brussels (Belgium) 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 Health Authorities
- Supports the global CMC regulatory strategy for assigned projects/products is consistent with global regulatory affairs practice, 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 with 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.

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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

  • Regulatory Device Scientist

    il y a 4 jours

    Anderlecht, Belgique UCB S.A. Temps plein

    **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...

  • Qc Device

    il y a 4 jours

    Anderlecht, Belgique U C B Temps plein

    We are looking for a looking for a high caliber, self-motivated **, QC Device & Packaging Project Manager **To strengthen our **Internal Manufacturing **team **, based in our UCB Campus based in **Braine l'Alleud, Belgium. **About the role** As our new team member: - You facilitate the analytical transfer of the new products to the Quality Control laboratory...

  • Qc Technician Packaging Device

    il y a 4 jours

    Anderlecht, Belgique U C B Temps plein

    Afin de renforcer notre **département Contrôle Qualité **, basé au sein de notre centre à Braine l'Alleud, Belgique, nous recherchons un **Technicien QC Packaging device **. Notre futur collègue intégrera l'équipe dédiée à l'Incoming Packaging en qualité d'analyste d'articles de conditionnement (primaire, secondaire et medical device) et des...

  • Global Medical Immunology Lead

    il y a 1 jour

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** **We are looking for a Global Medical Affairs Lead (Immunology) who is collaborative, insightful, and adaptable to join us in our Medical Affairs team, based in our Brussels office in Belgium or Slough Office in the UK.** **About the role** You will be working in a team that delivers medical and scientific leadership for...

  • Global Medical Lead Rare Diseases

    il y a 4 jours

    Anderlecht, Belgique UCB S.A. Temps plein

    Make your mark for patients. We’re here because we want to build the future and transform patients’ lives for the better. At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care...

  • Senior Medical Grant Funding Lead

    il y a 4 jours

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Medical Grants Funding Lead** to join us in our **External Funding**team, based in our any of our Brussels or Braine (Belgium) or Slough (UK) offices. **About the role** This role will manage the strategic review and approval processes relevant to the grant categorization and works externally with the...

  • QA Officer

    il y a 4 jours

    Anderlecht, Belgique U C B Temps plein

    We are looking for a self-motivated **QA Officer - Analytical Services / Quality Control **who is enthusiastic to join us in our **Quality Assurance, Braine Technical Ops **team, based in our UCB Campus located in **Braine-l'Alleud **in **Walloon Brabant **, **Belgium **. **About the role** Your main focus will be: - the Quality Control operations related...

  • Quality Systems Officer Utilities

    il y a 4 jours

    Anderlecht, Belgique U C B Temps plein

    We are looking for a **QA Systems Officer **to join us in our **QA Systems & Continuous Improvement Team **team, based in our UCB Campus office in Braine-l'Alleud, Walloon Brabant, Belgium. **About the role**: - You promote Quality and Operational Excellence and cultivate "Quality Culture", "Compliance Awareness", "Continuous Improvement Attitude" &...

  • Program Patient Safety Lead

    il y a 6 jours

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** **We are looking for a Program Patient Safety Lead**who is passionate, agile, and detail-oriented to strengthen our Early Clinical Development Benefit Risk and Medical Safety Unit team. This role can be based in one of our hubs in **Braine l’Alleud, Belgium (preferred); Slough, UK; or Raleigh, US**. **About the...

  • Head of Pv Innovation

    il y a 6 jours

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Head of Pharmacovigilance Innovation** to join us in our **Global Pharmacovigilance** team, based in any of our Brussels (Belgium), Slough (UK) or Raleigh (US) offices. **About the role** Reporting to the Head Vigilance, Systems & Innovation, as member of their leadership team (LT), the Head...