Compliance

• The Quality & Regulatory Administrator will work within the QCRS team to support on Quality, Regulatory and Compliance matters. The QCRS team are a central support team to all Uniphar Medtech Businesses. The primary purpose of the role is to manage the ongoing maintenance of our regulatory requirements ensuring we meet and exceed our contractual and regulatory obligations, providing best practice in QMS.
• Responsibility for identifying regulatory requirements within Medical Device Regulation. Understanding legislation and applying it to each Business.
• Review and approval of Regulatory documentation for new vendor and product set up.
• Recording and monitoring of classification of products and identification of any registration or licencing requirements.
• Overseeing and managing inbound queries to the QCRS team from Suppliers, Customers, internal stakeholders & Competent Authorities.
• Contributing to preparation of KPI reporting for the team.
• Supporting on administrative tasks as required.
• Assisting in carrying out internal audits & preparing for external audits.
• Provide cover & support in other areas of the team during periods of high volume or annual leave.

Quality and Regulatory Administrator

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Director, Regulatory Advisory – Implementations