Compliance and Regulatory Expert
This senior role oversees the entire quality and regulatory framework to ensure adherence to international standards, statutory requirements, and health and safety regulations.
* Main Responsibilities:
* Promote and implement a robust Integrated Management System (IMS).
* Evaluate and guarantee compliance with ISO 9001, ISO 13485, ISO 27001 certifications, and ISO 17025 accreditation.
* Lead corrective and preventive actions (CAPAs) teams.
* Oversee document control, change management processes, and validation of new equipment and materials.
* Regulatory Compliance:
* Ensure compliance with MDR/IVDR, GDP guidelines, and applicable health regulations.
* Coordinate product registration, submissions via EUDAMED, and MHRA.
* Monitor regulatory updates and implement internal policy changes.
* Leadership & Continuous Improvement:
* Mentor and develop the Quality & Regulatory team.
* Drive improvement initiatives across quality and compliance processes.
Requirements:
* Degree in Science, Quality Management, or relevant field.
* At least 5 years' experience in Quality Assurance and Regulatory Affairs within healthcare, medical devices, or pharmaceutical sectors.