Director, Quality Assurance Management Systems & Regulatory Affairs, PKNM Solutions Sàrl, Switzerland
Aikaterini Zisaki is a Quality Assurance Management Systems & Regulatory Affairs Specialist and Director to PKNM Solutions QMS/Regulatory Affairs Division. In an environment where regulatory developments can reshape industries, particularly in sectors like the pharmaceutical, MedTech and IVDs with or without AI industry, regulatory intelligence stands as the compass guiding professionals through the intricacies of compliance. The art of data analysis emerges as an indispensable skill of Aikaterini Zisaki, unlocking the potential to transform raw data into actionable insights that drive informed decision-making. In parallel with her skills like the exceptional planning and analytical capabilities foresight her integral to navigate the complexities of regulatory affairs, ensuring preparedness for shifts in the Quality and Regulatory landscape. This comprehensive understanding for more than 12 years forms the cornerstone of designing and implementing effective regulatory strategies, enabling Aikaterini Zisaki to navigate through the nuanced landscape of regulatory affairs with precision for the design, development, implementation, verification and validation and clinical evaluation of medical, IVDs and medicinal products. Effectively steering several teams globally through regulatory submissions, compliance assessments within the intricate landscape of laws and regulations are based on her advanced scientific background and working experience with an in depth understanding of the business objectives in full compliance of either ISO 9001, ISO 13485, ISO 27001 and the QM and Technical documentation of the regulatory requirements of MDD 93/42, MDR Regulation (EU) 2017/745, IVD Directive 98/79/EC and IVD Regulation (EU) 2017/746. Additionally, she serves as Auditor and Technical Assessor for EU Designated Notified Bodies as per MDR, as well as a Consultant to the IVD Prequalification Team of WHO in Geneva.
One of her significant achievements is the combination of her multidisciplinary background commencing from Chemistry, Clinical Biochemistry and Clinical and In Silico Pharmacology through her studies towards the possessing a diverse set of skills navigating the complexities of regulatory requirements and compliance standards in pharmaceuticals, biotechnology, and medical devices industries created the comprehensive understanding of the complex and ever-evolving regulatory environment through her “hands-on” long lasting experience.
