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.


  • 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

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!

Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha


Christopher O'Toole

Contact Consultant

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

How to Get the Most out of Psychometrics in HR

Caroline Ward speaking at CIPD event 1, Cork, Oct2016
Last Wednesday morning Collins McNicholas in conjunction with the CIPD had the pleasure of co-hosting an event focused on the topical area of Psychometrics in HR. A large crowd gathered at the splendid Maryborough Hotel for a very informative presentation. CIPD Chairperson Margaret Collins began proceedings before introducing Rory Walsh, Regional Manager of CollinsMcNicholas Recruitment […]
read whole article

Budget Basics 2017

Scales with money
Tuesday afternoon, Ministers Noonan and Donohue presented the budget for 2017 to the Dail. It included a number of expected measures, along with some interesting talking points. It’s very easy to get lost in the stats, but what implications does this really have? At a breakfast briefing this morning, hosted by RBK, Ulster bank and […]
read whole article

Job Seekers Guide

Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more