Job Opportunity
We are seeking a Senior Technical Specialist to support and guide device development programs throughout the design and development lifecycle.
* Evaluate compliance with design control requirements outlined in our Quality Management System, relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971).
* Maintain and provide guidance on the contents of Design History Files for development programs, including associated activity plans and timelines.
* Collaborate with affiliated sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
* Assess compliance with design control requirements of acquired combination products and medical devices, into our Global Device Development product portfolio.
Required Expertise
* 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 implementing device design controls and ISO/FDA requirements as applicable to device design