Senior Medical Device Development Leader

4 days ago


Dublin, Dublin City, Ireland beBeeScientist Full time €80,000 - €120,000

Job Description:

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  • Lead the design, development and performance evaluation of drug-device combination products to ensure they meet regulatory and quality standards.">
  • Develop technical excellence, innovation and patient-centric solutions by driving technical expertise in Combination Product development.">
  • Collaborate with drug product and device teams during combination product development to ensure formulation and manufacturing development activities are compatible and align with device development.">
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Requirements:

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  • Degree in Science/Engineering (Master's preferred).">
  • 7+ years' experience in pharmaceutical and/or medical device development.">
  • Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485.">
  • Experience in the development and validation of analytical methods.">
  • Experienced in application of statistical techniques for data analysis.">
  • Experience of writing and supporting regulatory submissions.">
  • Highly driven and motivated person who can work as part of a flexible, dynamic team.">
  • Well-developed communication skills to lead or facilitate effective discussions.">
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Benefits:

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  • This role requires some travel.">
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Other Information:

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A highly skilled professional is required to join our team on a permanent basis.



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