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• Support and provide guidance for device development programs throughout the design and development lifecycle for Combination products, including prefilled pens, prefilled syringes, auto-injectors, and medical devices, by ensuring compliance with design control requirements outlined in Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971).
• Establish, maintain and provide guidance on the contents of Design History Files for development programs, for various program types – in-house design authority, collaborative development, and acquired programs; this shall include associated activity plans and timelines.
• Collaborate with, and influence, affiliated sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
• Support the integration, and assess compliance with design control requirements, of acquired combination products and medical devices, into the Global Device Development product portfolio.

Support Risk Management activities for development programs through the implementation of ISO 14971:2019

What you'll need to succeed

• Education – Degree / Masters in engineering or science/life science
• Industry – Medical Device or Pharmaceutical (with devices)
• Min 5–7 years at similar level/ or 5–10 years general experience in industry
• Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
• Experience in the implementation of device design controls and ISO/FDA requirements as applicable to device design

Demonstrated understanding of GMP, Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
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