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Engineering Supervisor -Complaint Handling and Regulatory Re

Job Title: Engineering Supervisor -Complaint Handling and Regulatory Re
Contract Type: Permanent
Location: Galway
Industry:
REF: 91480
Job Published: 6 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533


Engineering Supervisor - Complaint Handling and Regulatory Reporting Department

Our client, a medical device company in Galway are currently looking to recruit an Engineering Supervisor for their site.


Our Offer
  • You will be responsible for the supervision of complaint handling activities for a wide range of products. You will be responsible for managing timely approval of regulatory reporting decisions.
  • You will also be responsible for the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies.
  • You will also support the coordination of cross functional responses to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
  • You will also ensure adequate support of complaint trend analysis and annual post market surveillance reports for various products.
  • You will also support complaint handling harmonization initiatives with other sites globally.
  • You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
  • You will contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.
  • You will also lead critical problem solving initiatives within the department and coach or mentor other team members.
  • You will supervise direct reports and manage their performance and support them to enable their development within the organization.

Qualifications
Your Profile
  • We are looking for a qualified person to Third Level 8 Degree in a relevant Technical qualification and desirably with 5-8 years relevant experience or 3-6 years with a Masters qualification.
  • You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
  • Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
  • People management or coaching experience is desirable.
  • Candidates must be able to think critically and make sound decisions and experience in Complaint handling or risk management would also be desirable.
  • Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour
  • You are a good communicator and fluent in English, both in writing and speaking.

For further information on this Engineering Supervisor role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie

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