Job Title: Medical Device Development Expert
About the Role:
We are seeking a highly skilled Medical Device Development Expert to join our team. As a key member of our development program, you will be responsible for ensuring compliance with design control requirements and relevant regulations.
Key Responsibilities:
* Support and provide guidance for device development programs throughout the design and development lifecycle.
* 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.
* Support the integration and assess compliance with design control requirements of acquired combination products and medical devices into the Global Device Development product portfolio.
* Implement ISO 14971:2019 for Risk Management activities.
Requirements:
* Education – Degree / Masters in engineering or science/life science.
* Industry experience in Medical Device or Pharmaceutical (with devices).
* Minimum 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.
* Demonstrated understanding of GMP, Quality Management System, and relevant Regulations.
Benefits and What's Next:
To succeed in this role, you will need to have a strong understanding of device development and regulatory requirements. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.