Regulatory Affairs Lead
2 days ago
BioTalent is looking for a seasoned Quality Manager & Responsible Person to take on a senior leadership role in our organisation. As a key member of our team, you will be responsible for ensuring product safety and regulatory adherence across Ireland and the UK.
About the RoleThis role offers an exciting opportunity to work with a global leader in healthcare compliance and quality management. As the EU GDP Responsible Person, you will be responsible for ensuring compliance with regulatory requirements and engaging with the HPRA.
- 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.
- 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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