Medical Device Regulatory Scientist
Il y a 5 mois
**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.
-
Medical Device Regulatory Scientist
il y a 3 semaines
Anderlecht, Belgique UCB Temps pleinMake 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 any of our Brussels (Belgium), Bulle (Switzerland) or Slough (UK) offices The Medical Device Regulatory Scientist is responsible for regulatory activities for marketed and development medical...
-
Regulatory Cmc Scientist
Il y a 6 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Regulatory CMC Scientist - Small Molecules** to join us in our **Regulatory Affairs** team, based in any of the following locations: Brussels (Belgium) or Slough (UK) **About the role** Define the strategy, planning and preparation (writing and review) of CMC documentation and sections for regulatory...
-
Regulatory Scientist
il y a 1 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Regulatory Scientist - Rare Disease** to join us in our **Global Regulatory Affairs** team, based in in either of our Brussels (Belgium) or Slough (UK) offices **About the role** Prepare and deliver regulatory operational plans for assigned projects/products within a specific region as agreed with the...
-
Regulatory Scientist
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Regulatory Scientist - International Markets** to join us in our **Regulatory Affairs** team, based in our headquarters in Brussels, Belgium. **About the role** The Regulatory Scientist International Markets is responsible for developing and implanting the international markets regulatory strategy in...
-
Safety Writing Scientist
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Safety Writing Scientist** to join us in our **Patient Safety & Medical Management** team, based in any of our Brussels (Belgium), Slough (UK) or Raleigh (US) offices. **About the role** Scientific analysis and writing acumen to effectively articulate for benefit-risk assessments, safety risk...
-
Global Submission Lead Cmc
Il y a 2 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Global Submission Lead CMC & Devices** to join us in our **Regulatory Excellence** team, based in our Brussels (Belgium) or Slough (UK) offices **About the role** The primary purpose of the Global Submission Lead CMC & Devices is to bring project management solutions to the Global Regulatory Affairs...
-
Eu Labelling
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **European Labelling & Promotional Scientist** to join us in our **Regulatory** team, based in our Brussels, Belgium office **About the role** Provides European Labelling & Promotional Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and...
-
Regulatory Associate
Il y a 5 mois
Anderlecht, Belgique Pfizer Temps pleinDo you want to be part of an international, innovative, world-class pharmaceutical company committed to putting patients first. Pfizer has always evolved with the changing needs of the people who rely on us to create a healthier world. Guided by our four values: Courage, Joy, Equity and Excellence, our breakthrough culture lends itself to our dedication to...
-
Patient & Regulatory Community Lead 1
Il y a 3 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Patient & Regulatory Community Lead, Epilepsy Brands **who has **strong communication and relationship building with a patient-centric mindset** to join us in our **strategic planning and operations’ team**, based in our **Headquarters in Brussels, Belgium (preferred) or in Atlanta, Raleigh, Boston,...
-
Medical Strategy Lead Dermatology
Il y a 6 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a** Medical Strategy Lead Dermatology** for the **ABN region (Alps, Benelux & Nordics) **who has a passion for creating impact for patients, to come and join our fantastic **ABN Medical Affairs Team - the role can be **based in** either Netherlands, Belgium or Switzerland.** **About the role** You are as...
-
Ieu Medical Strategy Lead Axspa
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **axSpA Medical Strategy Lead Europe **to join us in our European Rheumatology Medical team based in our **HQ, Brussels, Belgium** (preferred) or one of our major EU hubs. **About the role** The European Medical Strategy Lead axSpA will provide medical & scientific strategic input and expertise for the...
-
Global Medical Lead Dee
Il y a 2 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** **About the Role** As the Global Medical Lead for DEE & Epilepsy, you will provide medical expertise and strategic leadership to drive the right adoption of our solutions, elevate the standard of care, and improve patient outcomes. You will play a critical role in developing and executing the global medical **disease...
-
Medical Impact
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a** Medical Impact & Digital Strategy Lead **who is agile and innovative to support the** Patient Value Neurology Group** to be ideally based in** Belgium or **UK, **other European countries can also be considered. **About the role** EU Medical Impact & Digital Lead will transform, provide medical input...
-
Medical Solutions Lead Imm Derm Be
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Medical Solutions Lead dermatology BeLux** who is fluent in French, Dutch and English and knows the local healthcare compliance and pharma environment to join us in our **ABN (Alps, Benelux, North European) immunology Medical** team, based in our Headquarter, Anderlecht, **Belgium** **About the...
-
Data Scientist
Il y a 5 mois
Bruxelles Anderlecht, Belgique Ypto NV Temps pleinWe are seeking a highly motivated and skilled Data Scientist to join our team and help use improve the Belgian rail services by leveraging our data. In this role, you will analyse and interpret large sets of data and turn that information into actionable insights that drive business decisions. You will be responsible for developing and implementing advanced...
-
Senior Medical Grant Funding Lead
Il y a 2 mois
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...
-
Assistant Bone Health Medical and Patient Community
Il y a 2 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a** Health Medical and Patient Community Assistant **to join us in our **Bone **team, based in our **Headquarters, Brussels, Belgium** **About the role** **Who you’ll work with** This position involves supporting the Head of Medical Community Strategy and the Head of Patient and Healthcare Communities...
-
Digital Clinical Solutions Lead
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for an **Digital Clinical Solutions Lead** to join us in our **IT Digital Clinical Operations team** **About the role** The IT Digital Clinical Solutions Lead is a global role leading and influencing various digital business transformation initiatives within the “Human Centric Health (HcH)” program across...
-
Head Global Labelling Promo.
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Head of Global Labelling, Promotion & Advertisement** to join us in our **Global Regulatory Affairs** team, based in either our Brussels, Belgium or Atlanta, US offices. **About the role** The Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT)...
-
Head Global Labelling, Promotion
Il y a 5 mois
Anderlecht, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Head of Global Labelling, Promotion & Advertisement** to join us in our **Global Regulatory Affairs** team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices. **About the role** The Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team...