Quality Assurance & Reg Affairs Director – Galway | Collins McNicholas

Quality Assurance & Reg Affairs Director – Galway

  • Reference: GJ43370
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

Reporting directly into the Chief Executive Officer, the QA & RA Director is responsible for maintaining and ensuring that the Company’s Quality Management System complies with FDA, ISO 13485 and international medical device regulatory standards.

Responsibilities:

  • The QA & RA Director will act as the management representative for the company.
  • The duty of this task is to act as the point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.
  • Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.
  • Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files.
  • Responsible for the quality and regulatory control for products in which the company is the Legal Manufacturer.
  • Manage and maintain compliance to ISO13485 requirements.
  • Responsible for responding and reporting incidents to all approved markets.
  • Responsible for the Customer Complaint System.
  • Responsible for managing product failures and appropriate corrective actions.
  • Responsible for defining the Company’s quality goals each year. Managerial responsibilities
  • Manage the Quality Assurance and Regulatory department.
  • Develop yearly target budget and capital plan.
  • Manage QA & RA expenditure against budget.

Skills, Experience and Qualifications:

  • A bachelor of Science Degree with 10+ years’ experience in Quality Assurance and Regulatory affairs within the medical devices field of use.
  • At least 2 years management experience

For a confidential discussion and more information on the role/company please contact christopher.otoole on 091-706713 or email christopher.otoole@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Christopher O'Toole

Contact Consultant

  • Christopher O'Toole
  • Recruitment Consultant
  • 091 706713
  • Connect with Christopher

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