Healthcare Compliance Officer

2 days ago


Dublin, Dublin City, Ireland BioTalent Full time
Compliance and Quality Leader

BioTalent seeks a Quality Manager & Responsible Person to lead our efforts in ensuring compliance and quality across Ireland and the UK. This role involves overseeing regulatory activities, managing and improving our Quality Management System (QMS), and providing training and guidance on regulatory and quality compliance.

About the Role

In this position, you will have the opportunity to act as the EU GDP Responsible Person, ensuring compliance with regulatory requirements and engaging with the HPRA. You will also be responsible for leading regulatory inspections, customer audits, and quality governance processes.

  • Key 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.
Requirements
  • Education:
  • Bachelor's degree in Regulatory Affairs, Life Sciences, or equivalent experience.
  • Experience:
  • Extensive experience in Regulatory Affairs and Quality Management, preferably within the medical device or pharmaceutical industry.
  • Skills and Qualifications:
  • 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.


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