Job Summary
Our client, a leading Pharmaceutical company in Dublin, is seeking a highly skilled Senior Device Development Specialist to join their team. The successful candidate will be responsible for providing technical guidance and support for device development programs throughout the design and development lifecycle.
Main Responsibilities
* Ensure 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
* Collaborate with 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
Requirements
* 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)
About You
As a Senior Device Development Specialist, you will possess excellent communication and collaboration skills, with the ability to work effectively in a fast-paced environment. You will have a strong understanding of device development and manufacturing operations, with experience in implementing device design controls and ISO/FDA requirements. You will also have a demonstrated understanding of GMP, Quality Management System, and relevant Regulations.
We Offer
A competitive salary and benefits package, including opportunities for career growth and professional development.