Aspiring Regulatory & Quality Affairs Specialist | ISO 13485 Certified Internal Auditor | EU MDR | MSc Business Admin &...

4/2023 – 6/2025

Implemented quality management processes across the product lifecycle, ensuring alignment with regulatory
requirements and successful quality assurance integration in Medical Devices and Technology, adhering to ISO 13485
standards.
Supported regulatory requirements for the successful transition of legacy devices from MDD to MDR, ensuring full
compliance with updated standards and efficiently coordinating approval processes with notified bodies.
Enhanced Quality Management systems by actively participating in regulatory audits, implementing Corrective and
Preventive Actions (CAPAs), and refining Standard Operating Procedures (SOPs) for Regulatory Affairs, achieving a
15% reduction in quality issues through effective risk management and conducting gap analyses to identify deviations and
align with new regulatory requirements.
Implemented comprehensive regression testing protocols for the Klenico web app, ensuring a high standard of quality
with seamless releases and enhanced user satisfaction in Medical Technology, aligning with regulatory standards.
Spearheaded the development of compliance documentation adhering to MDR and ISO-13485 standards, facilitating a
10% increase in audit success rates through meticulous regulatory adherence and processing CAPAs.
Streamlined the complaint handling procedures within the Quality Management System (QMS), resulting in a 15%
improvement in issue resolution times.
Engaged with regulatory and product teams to seamlessly integrate quality protocols into new feature rollouts, boosting
project alignment and ensuring conformity with Medical Device standards.
Streamlined the update process for Change Request Documents, SOPs, and Risk Management frameworks (FMEA),
resulting in enhanced compliance and reduced risk exposure across the development lifecycle.

Regulatory Affairs Manager