Head of Quality Assurance and Regulatory Affairs
Medical Device Manufacturer
This is a hands on leadership role for someone who has already led MDR work and wants full ownership of Quality and Regulatory.
A medical device manufacturer in Tullamore is appointing a Head of Quality Assurance and Regulatory to lead the QA and Regulatory function and take the site through MDR compliance. You will have direct access to the decision makers and the authority to implement change.
This role suits someone who wants responsibility, visibility and the chance to build systems properly rather than maintain what already exists.
What you will do:
* Lead Quality Assurance and Regulatory end to end
* Own and evolve the Quality Management System
* Lead EU MDR implementation and ongoing compliance
* Act as Person Responsible for Regulatory Compliance under Article 15
* Manage notified body relationships and regulatory submissions
* Lead audits, CAPA, risk management and continuous improvement
* Build, develop and mentor the QA and Regulatory team
What we are looking for:
* Strong experience within medical device manufacturing
* Proven experience leading EU MDR implementation
* Expert working knowledge of ISO standards and regulatory frameworks
* Credibility to operate as PRRC
* Confident leadership style that works on the floor as well as at senior level
What is on offer:
* Excellent base salary with a competitive benefits package
* Relocation package if required
* Direct influence over how quality and regulatory is run on site
* A role with a clear runway, where you can make your mark over the next 12 to 24 months
* Long term career opportunity within a growing manufacturer
Interested:
If you are open to a confidential discussion, apply via Indeed and you will be contacted directly. All applications will be treated in strict confidence.
Job Types: Full-time, Permanent
Pay: From €1,000.00 per year
Benefits:
* Company pension
* Employee discount
* Flexitime
* On-site parking
* Private medical insurance
* Relocation assistance
Work Location: In person