Lead global QA/RA strategies for medical device and IVD manufacturers

• Define and execute global quality and regulatory strategies in line with MDR, IVDR, ISO 13485 and ISO 14971 
• Act as executive advisor and primary authority interface for Notified Bodies and regulatory authorities 
• Own, design, and continuously improve ISO 13485-compliant QMS, including governance, processes, and KPIs 
• Lead and support internal, supplier, and regulatory audits and inspections, including readiness and remediation activities 
• Guide organizations through MDR/IVDR transitions, legacy product remediation, and portfolio optimization 
• Establish and oversee risk management, PMS, and PMCF frameworks to ensure sustained compliance 
• Lead, mentor, and align cross-functional and international teams in matrix environments

Responsible for technical documentation and regulatory affairs for IVD products within a regulated manufacturing environment. 

• Led regulatory and technical documentation strategy for IVD portfolios in accordance with EU regulatory requirements 
• Ensured compliance of technical files and design documentation throughout the product lifecycle 
• Acted as key contact for regulatory authorities and external partners 
• Supported audits, inspections, and conformity assessments 
• Collaborated closely with R&D, Quality, and Manufacturing to align documentation and regulatory requirements 

Supported the development and maintenance of technical documentation for medical devices and IVD products. 

• Prepared and maintained technical documentation and design dossiers 
• Supported regulatory submissions and lifecycle documentation updates 
• Coordinated documentation activities across internal stakeholders 
• Gained strong foundational expertise in regulatory compliance and quality documentation processes