Global Regulatory CMC Scientist - Medical Devices

Contenido de trabajo

To strengthen our Global Regulatoryfunction, based in HQ in Brussels, Belgium we are looking for a talented individual to fill the position of Medical Device Regulatory CMC Scientist.

As a Medical Device Regulatory CMC Scientist, you will have the following responsibilities:

• Regulatory activities for marketed and development of In vitro diagnostic (IVD) devices within the scope of the Neurology, Immunology, and New Medicines PVSs.
• Helping to define the strategy, planning and the preparation of devices documentation including risk determinations for clinical trial studies and supporting the development of sections for regulatory submissions from the assigned projects within a global perspective to achieve timely approvals to meet business needs.
• Providing devices regulatory input and/or leadership on cross functional sub teams (Global Regulatory Affairs (GRA) Teams and PVUs, IT, Clinical Development and Operations).
• Leading and ensuring adequate provision of regulatory input to all Health Authority (HA) and Notified Bodies (NBs) interactions on IVD devices matters in all regions.
• Leading or providing input to internal regulatory business initiatives and cross functional work streams as assigned.
• In alignment with the global regulatory strategy, responsible for strategy, planning, definition of content, preparation, review and approval of global submissions for IVD devices in assigned projects/products to achieve timely approvals to meet business needs.
• Responsible for working with the IVD partner to meet Clinical development timelines in preparing and maintaining devices Technical Files aimed to obtain CE Marks, NBs Opinions or FDA clearance on assigned projects.
• Interacts with HAs/NBs where appropriate during the IVD development process
• Identifies supporting devices documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree
• Relevant experience in the pharmaceutical industry or a regulatory authority in a Devices capacity, preferably experience in IVD devices
• Knowledge in devices and drug manufacturing processes
• Knowledge of IVD, MDR, 510(k), IMDRF requirements
• Demonstrated competence in contributing on cross-functional teams and operating within a matrix organizational structure
• Ability to input devices expertise into the global regulatory strategy and global planning, to indemnify the critical issues and share lessons.

Why you should apply

At UCB, we welcome passionate individuals who thrive on change and are ready make their mark for patients. Working for us, you will discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact while putting continuous efforts into cultivating a workplace culture where everyone feels included, respected and has equitable opportunities. Through meaningful recognition and a motivating atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe that you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.