Bhaveeka DattaniSr. Manager, Regulatory Affairs, Devices at Allergan, UK
Conclusive QARA professional with over 10 years’ experience of working within a diverse environment across a comprehensive product portfolio including Fast Moving Customer Goods in Health and Personal Care, Germ Protection, Medical Devices, Drug Delivery Systems and Drug inhalation. Experience of working on continuous improvement programs within a quality controlled manufacturing setting to improve compliance including both product development/analysis and process validation within both sterile and other manufacturing environments. Proficiency in regulatory compliance across the EU region (leading risk management activities, compiling Technical Files for CE-Marking, managing notified body audits, IEC testing for devices, 510(k) submissions) and emerging markets with expertise in market regulatory approval.