Join a Global Leader in Healthcare Compliance & Quality
Are you a quality-driven professional ready to take on a leadership role in a dynamic, fast-paced environment? We are seeking a Quality Manager & Responsible Person to oversee compliance and regulatory activities across Ireland and the UK. This is a fantastic opportunity to work with a market-leading organisation and play a critical role in ensuring product safety and regulatory adherence.
This Role Will Offer You:
* The opportunity to act as the EU GDP Responsible Person, ensuring compliance with regulatory requirements and engaging with the HPRA.
* Leadership in managing and improving a Quality Management System (QMS) across Ireland and the UK.
* A key role in maintaining licenses, certifications, and supplier quality oversight.
* The chance to work in a hybrid role with flexibility and professional development opportunities.
Responsibilities:
* Act as the EU GDP Responsible Person, ensuring compliance with Good Distribution Practices (GDP) and regulatory obligations.
* Manage and maintain the QMS to align with GDP, ISO 9001, and ISO 13485 standards.
* Oversee supplier qualification, internal audits, CAPA processes, and risk management programs.
* Lead regulatory inspections, customer audits, and quality governance processes.
* Provide training and guidance on regulatory and quality compliance across the organisation.
You Will Bring the Following:
* Bachelor's degree in Regulatory Affairs, Life Sciences, or equivalent experience.
* Extensive experience in Regulatory Affairs and Quality Management, preferably within the medical device or pharmaceutical industry.
* Strong knowledge of GDP, ISO 9001, ISO 13485, and EU/UK MDR regulations.
* Experience managing regulatory body communications, hosting inspections, and implementing risk management strategies.
* Excellent communication, leadership, and problem-solving skills with the ability to work independently and within a matrix organisation.
If you’re ready to take on a challenging and rewarding role in a global healthcare company, apply now!
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