Senior Medical Product Assurance Specialist

5 days ago


Galway City, Ireland Aerogen Ltd Full time

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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