Guneet Kaur

Background

About Guneet Kaur

• Pharmaceutical professional with proven expertise in Medical Device and Pharmaceutical Regulatory Affairs Quality Management Regulatory Compliance Audit Management and Risk and Fraud Management • Possess expertise in preparation and filing of Class III Medical Devices in line with the EU MDR for CE marking • Experienced in extending CE marked products to other markets (Malaysia Australia UK Saudi Arabia and Switzerland) • Management of MDR MDSAP and CE Post Surveillance Audits for Class III Medical Devices • Sound knowledge of ISO 13485 ISO 14971 and EN 62366-1 • Conducting Critical Supplier vendor and third-party audits as a part of a Medical Device Manufacturing company • Lead Quality Management initiatives conducting internal audits supporting external Client audits and Inspections • Working with regulatory authorities organisations and notified bodies for Accreditations Certifications and other Compliances (Medical Device Single Audit Program (MDSAP) ISO 13485 ISO 17025) • Provide leadership and advice on a full range of compliance issues (CAPA management reporting Inadvertent Changes (ICs) Change Controls (CRs) and HERTs • Develop framework of SOPs compliance metrics reporting trainings for pharmaceutical consulting firm • Part of Big 4’s Life Sciences’ Risk Consulting team provide risk management risk advisory and fraud investigation • Worked in Drug Regulatory Affairs department of global pharma company manage filings of ANDAs/ ANDSs/ Supplements that gained approval of new drug molecules in US & Canadian markets • Manage the lifecycle of commercial products sustaining authorization/approvals and sales of US FDA and Health Canada approved commercial products in the US and Canadian markets • Knowledge of US FDA drug regulatory guidelines US CFR GCP FCPA (Foreign Corrupt Practices Act)