Quality Manager & RP

BioTalent Ltd; Dublin; Hybrid; EUR 55,000 - 80,000; Full time

Job summary

A leading company in healthcare compliance is looking for a Quality Manager & Responsible Person to ensure regulatory adherence across Ireland and the UK. This leadership role involves overseeing the Quality Management System, managing licenses, and improving compliance practices. Candidates should have a background in Regulatory Affairs with strong knowledge of industry standards.

Benefits

Professional development opportunities

Flexible working arrangements

Qualifications

• Extensive experience in Regulatory Affairs and Quality Management.
• Strong knowledge of GDP, ISO 9001, ISO 13485, and EU/UK MDR regulations.
• Experience managing regulatory body communications and hosting inspections.

Responsibilities

• Act as the EU GDP Responsible Person ensuring compliance with regulatory obligations.
• Manage and maintain the QMS to align with GDP, ISO 9001, and ISO 13485.
• Lead regulatory inspections and quality governance processes.

Skills

Leadership

Problem Solving

Communication

Education

Bachelor's degree in Regulatory Affairs, Life Sciences or equivalent

Job description

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!