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R&D Regulatory Affairs Specialist - Expired

Job Title R&D Regulatory Affairs Specialist
Job Type Permanent
Industry
Salary Up to €0.00 per annum
Location Clare, Republic of Ireland
Start Date ASAP
Our Reference BBBH1382_1581959453
Job Advertised 7 months ago

R&D Regulatory Affairs Specialist



Company

Vitalograph is one of the world-leading manufacturers of medical Spirometers, used in the diagnosis of respiratory disorders, and advanced high-reliability systems used in clinical drug trials. Based in Ennis, Co. Clare for over forty years, we now wish to recruit a R&D Regulatory Affairs Specialist to join our existing R&D team.



Role

Reporting to the CTO, this role requires someone with at least 2-3 years' experience in a regulated environment. They will be familiar with activities required to ensure that Vitalograph's product and software development projects and deliverable are compliant with industry standards and regulations.

Duties:

  • Ensure that product development QMS SOPs are current and compliant.
  • Conduct internal audits on product development projects to ensure compliance with regulatory requirements.
  • Assist with the completion and ongoing maintenance of device technical files.
  • Identify and mitigate project risks.
  • Liaison with cross-functional R&D teams and intercompany project management teams.
  • Regular communication of project status to relevant stakeholders.

Minimum Requirements:

  • Qualifications: 3rd Level Degree in an Engineering or Science discipline
  • 2-3 years in industry role with relevant experience
  • Exposure to requirements of EN ISO 13485, MDD, MDR, FDA 510(k)
  • Good knowledge of product development life-cycle processes
  • Excellent communication skills both written and verbal
  • Experience with Microsoft Excel, Word, Outlook

The following skills would be advantageous:

  • Familiarity with Agile/Lean work practises
  • Experience with product testing and certification
  • Experience dealing with 3rd party test houses
  • Experience acting as Subject Matter Expert in company audits

If you are interested in the above position please email a CV to careers@vitalograph.ie
For more information on Vitalograph Ireland Ltd. Please visit www.vitalograph.ie

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