The Quality Regulations Specialist will support the MedTech Quality function by providing regulatory query support, and vendor approval and management.
The role ensures efficient, compliant execution of quality tasks across storage, distribution and supply contributing to strong regulatory compliance across the MedTech division.
This role covers compliance with EU MDR, ISO 13485, GDP, ISO 9001, and product specific regulatory requirements.
The Quality Regulations Specialist has one direct report and will work closely with the Regulatory SME to support the business needs.
Responsibilities
Author documents relevant to both medical devices and medicines, including SOPs, work instructions, and forms.
Support with audit and inspection readiness.
Ensure compliance with EU MDR for medical devices through document review (e.g., CE documentation, DoCs, device classification records).
Review and approve requests for new Vendor approvals.
Support other quality activities and projects where required.
Monthly KPI reporting
Complete Quality and Regulatory Supplier questionnaires
Vendor review, approvals and management.
New item / product approval
Support with Internal audits.
Essential
Proficiency in Microsoft Office.
Experience with QMS/e-QMS platforms.
Strong understanding of regulatory environments for both medical devices (MDR/ISO 13485) and medicinal products (GDP).
Excellent communication skills.
Strong analytical, problem‑solving, and organisational abilities.
High attention to detail and accuracy in regulated documentation.
Proactive, solution‑oriented mindset with interest in continuous improvement.
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