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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