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Senior Quality and Regulatory Engineer

Reference:JCAO2707
Location: Galway
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Senior Quality and Regulatory Engineer-Start Up

Our client a well-funded start up with a management team with a proven track record in start up are currently seeking a Senior Sustaining QARA Engineer to join our team and work with us on expanding our innovative product portfolio and market roll-out. The position of Senior Quality and Regulatory Engineer will be responsible to provide technical and administrative quality and regulatory support to ensure maintenance of the Quality System Compliance, maintenance of existing products and timely introduction of new products subject to medical device regulations in both the E.U., U.S. and global regions.


Role/Responsibilities:

  • Lead the quality and regulatory aspects of next generation products.
  • Assist in Preparing applications to the Regulatory Body for clinical testing and marketing of new/modified medical devices (e.g., CE Submissions, 510(k)'s, IDE's, and Pre-Submissions)
  • Prepare required documentation as needed (e.g., doc-to-file 510(k) change management rationales, international change notifications).
  • Review of Regulatory guidelines as required.
  • Assist with risk management activities.
  • Assist and Coordinate review of regulation submissions and test protocols with Management.
  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
  • Escalate and/or present CAPA program to Quality Management.
  • Support Manufacturing and Project Teams in developing FMEAs, statistical plans, and process controls for appropriate support of results.
  • Work with Product Development team to assure that all aspects of Design Transfer activities are being met. Formulate product quality plans based on results of risk analysis and product documents.
  • Actively participate in the Supplier Management program. Audit the quality system of new and existing suppliers and prepare audit reports including recommendations.
  • Oversee supplier corrective actions as appropriate.
  • May be required to carry out internal audits, as necessary.
  • Support the appointed management representative
  • Assist in the release of product.
  • Other activities as business needs arise.

Skills/Experience:
  • Bachelor of Science required (or equivalent), with emphasis on life science or engineering.
  • Minimum of five years knowledge and experience with quality and regulatory requirements for medical devices (13485:2016, US FDA Quality System Requirements, Pre-Submissions, 510(k)'s, CE mark technical files and design dossiers).


For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 0860204322



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