Social network you want to login/join with:
Medical Device Regulatory Scientist, Slough
Client:
UCB Location:
Slough, United Kingdom EU work permit required:
Yes Job Reference:
05844a7e1e83 Job Description:
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 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 devices and combination 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 : 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 identify the critical issues and share lessons. Ability to synthesize 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!
#J-18808-Ljbffr
Client:
UCB Location:
Slough, United Kingdom EU work permit required:
Yes Job Reference:
05844a7e1e83 Job Description:
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 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 devices and combination 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 : 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 identify the critical issues and share lessons. Ability to synthesize 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!
#J-18808-Ljbffr
