Quality and Regulatory Affairs Manager
We are seeking a seasoned Quality and Regulatory Affairs Manager to lead our organization's quality management system. This role will be responsible for ensuring compliance with international standards, regulatory requirements, and health and safety legislation.
Key Responsibilities
* Develop and implement the Integrated Management System (IMS).
* Evaluate and maintain ISO 9001, ISO 13485, ISO 27001 certifications, and ISO 17025 accreditation.
* Streamline operations by integrating QMS processes across sites.
* Conduct internal audits, coordinate external audits, and ensure timely closure of findings.
* Manage corrective and preventive actions (CAPAs) and lead CAPA teams.
* Oversight document control and change control processes.
* Validate new equipment and materials, including training and monitoring.
Regulatory Compliance
* Evaluate and ensure MDR/IVDR, GDP guidelines, and applicable health regulations compliance.
* Manage product registration and regulatory submissions via EUDAMED and MHRA.
* Monitor regulatory changes and update internal policies accordingly.
* Act as primary liaison with regulatory authorities and notified bodies.
* Prepare and maintain technical documentation for regulatory compliance.
Health and Safety
* Ensure compliance with company Safety Statement and Risk Assessments.
* Provide health and safety training with external consultants and ensure protective equipment is available.
* Monitor workplace safety and implement risk mitigation measures.
* Manage supplier onboarding, qualification, and performance monitoring.
Requirements
* Degree in Science, Quality Management, or related discipline.
* 5+ years' experience in Quality Assurance and Regulatory Affairs within healthcare, medical devices, or pharmaceutical sectors.
* Strong knowledge of ISO standards, MDR/IVDR, and GDP guidelines.
* Proven experience in audits, CAPA management, and risk assessment.
* Excellent leadership, communication, and stakeholder management skills.