Device Development Assurance Specialist
Our client, a pharmaceutical company in Dublin, is seeking a skilled Device Development Assurance Specialist to join their team. This role will be responsible for ensuring compliance with design control requirements outlined in the Quality Management System and relevant Regulations.
Key Responsibilities:
* 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.
* 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.
* 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.
* Support Risk Management activities for development programs through the implementation of ISO 14971:2019.
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).