Job Title: Senior Medical Device Assurance Specialist
The role will focus on supporting device development programs throughout the design and development lifecycle for Combination products. This includes prefilled pens, prefilled syringes, auto-injectors, and medical devices.
Maintain Design History Files for various program types – in-house design authority, collaborative development, and acquired programs. Ensure objective evidence and controls are established as per program deliverables.
* Support integration of combination products into the Global product portfolio.
* Implement ISO 14971 risk management standards during the project lifecycle.
The ideal candidate should have direct experience with device manufacturing operations activities in a GMP environment.
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About The Role:
1. Education - Degree / Masters in engineering or science/life science is required.
2. Industry knowledge of Pharmaceutical or Medical Devices (with drug/device systems)
3. A minimum 5–7 years at similar level/ general industry experience of around 5-10 years would be ideal. u200B4Experience of managing software implementation processes for pharmaceutical companies would be beneficial to your application, It also involves Risk Management techniques like ISO/FDA requirements to ensure strict compliance across all environments ,