Senior Medical Product Assurance Specialist
5 days ago
Aerogen Ltd is a world leader in acute care aerosol drug delivery, headquartered in Galway with offices globally.
Our purpose is to transform patient lives and our ethos is to #discoverbetter.
We are looking for a Senior Medical Product Assurance Specialist to work with our R&D, Regulatory, Process Development, Clinical and Manufacturing Engineering functions.
The role will be primarily responsible for Medical Product Approval (MDR and FDA 510k), Design Assurance and Risk Management Activities.
- Collaborate with cross-functional teams to provide Technical and Quality expertise.
- Provide quality and technical input to stage gate design reviews, risk management, design verification/validation protocols and reports.
- Analyse products and processes for compliance with standards such as ISO 13485 & EU MDR.
A degree in Engineering, Technology or Science is required, along with minimum 3-5 years' experience in a regulated medical device or pharmaceutical company.
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