Gurge Phull
Manager - Medical Regulatory Affairs @Element Materials Technology
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WORK HISTORY
Manager - Medical Regulatory Affairs @Element Materials Technology
Experience includes pharmaceutical industry, IVDs, medical devices, pathology laboratory instrumentation and training. This embraces complete product lifecycle processes from product inception, R&D, and product development, to manufacturing, sales & marketing and post production. I am qualified lead auditor and thus able to address complex compliance issues.This wealth of knowledge allows me to act as a trusted advisor to Element’s clients. This expertise includes guiding them through complicated testing, quality and certification procedures, and ensuring that their regulatory procedures, product life cycle management, and post market surveillance and vigilance are carried out to the highest technical and professional standards.Regulatory Affairs and Quality Assurance ExperienceI have helped companies manage complex Regulatory Affairs and Quality Assurance projects including:• Planning and implementing of global regulatory compliance strategy for Medical Devices and IVDs• EU Medical Device Directives,(93/42/EEC, 90/385/EEC, 98/79/EC) product and CE mark compliance (Technical files, Design Dossiers, Risk management)• USA FDA product compliance / registration (DHF, PMA and 510K) and QSR regulations (CFR21part 820) • Worldwide product regulatory approvals• Liaison between Regulatory Authorities (EU competent Authorities, the FDA, notified Bodies and others) • Conduct product compliance and quality management inspections and audits (FDA-QSIT, Notified Bodies(MDD, ISO134585)• New product design and development management, from inception to market launch• Safety requirements of medical devices - EN 60601-1 • Reprocessing and Microbiology requirements of products• Sterilisation and Clean room requirements for Sterile product production• Labelling requirements, Packaging and Transport requirements of products• Toxicity and Biocompatibility, Clinical Investigations, Evaluations reports
EDUCATION
Unversity of Birmingham, Edgbaston, Birmingham UK
Doctor of Philosophy (Ph.D.), Chemistry
SKILLS
ABOUT GURGE PHULL
Experience includes pharmaceutical industry, IVDs, medical devices, pathology laboratory instrumentation and training. This embraces complete product lifecycle processes from product inception, R&D, and product development, to manufacturing, sales & marketing and post production for product sales in the EU, USA and worldwide. I am qualified lead auditor and thus able to address complex compliance issues.
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