Aurore Mulkens Email & Phone Number

Geelong, VIC, AU

Port Melbourne, Victoria, Australia

Victoria, Australia

Management advice, compliance auditing and related consulting services in the field of quality assurance for medical devices manufacturers and quality assurance for clinical research organisations in line with current guidelines and regulations (e.g., ISO 9001, ISO 13485, ISO 14971, ISO 14155, TGA and FDA regulations)

Port Melbourne, Victoria, Australia

Management of post-market activitiesPreparation of Post-Market Surveillance documents according to EU-MDR (PSUR, PMCF Report, PMS Plans)Implementation of post-market electronic database

Port Melbourne, Victoria, Australia

Support all quality assurance activities for QMSSuccessful MDSAP audit completionAssist in Design and Development documentation managementLeader of risk assessment and risk managementAdviser on clinical evaluation strategy and clinical investigation conduct

Port Melbourne, Victoria, Australia

Maintenance of ISO 13485 accreditation and continuous improvement of the Quality Management SystemImplementation of post-market surveillance according to MDRPreparation for MDSAP certificationEstablishment and improvement of clinical research policies and procedures in line with ISO 14155Management of clinical investigations in Australia and USALead.

Port Melbourne, Victoria, Australia

Successful maintenance of ISO 13485:2016 certificationImprovement of quality understanding with cross-departments support and complianceManagement of company policies, procedures and recordsManagement of audit programs; follow-up of CAPAs until resolutionMentoring junior quality staff

Geelong, VIC (Australia)

Quality management system for medical device (ISO 13485, FDA 21CFR Part 820 requirements)- Analysis and improvement of processes- Development and implementation and/or administration of policies, systems and procedures that assist the Organisation to achieve their objectives and meet regulatory responsibilities. Quality Assurance mentoringQMS auditor: ISO.

Melbourne, Australia

Implementation of ISO13485 QMS, and ongoing maintenance of certificationManagement of policies, procedures, records and reports for operations and clinical investigationsConduct of internal audits and audits of suppliersManagement of regulatory audits Management of Customer complaints CAPA handlingStaff training and mentoring

Melbourne Area, Australia

• Implementation of QMS according to ISO 9001, maintenance of certification
• Management of policies, procedures and records
• Conduct of internal audits of processes and studies
• Management of external audits by ClientsSupport in Staff training
• Conduct and supervise field training activities for new employees, and regular assessment visits of field CRAs

Melbourne Area, Australia

• Coordinate activities to set up and assist in the management of all aspects of a Clinical Trial in APAC region
• Management of clinical trials across Australia (VIC, NSW, QLD, WA and SA) and New-ZealandGeneral study-related activities for trial set-up (selection of investigators, pre-study visits, Ethics submission packages) and.
• Coordination of assigned studies, including provision of training, supervision and leadership for Clinical Research Associates working on assigned studies
• Structured feedback to Clients (Study Sponsors) with regular meetings/teleconferences
• Management of trial sites budgets and payments Mentoring and training of new and junior staff

Prague, Czech Republic

Consultant for clinical trials in Czech Republic:- local (country) trial management: set-up, RA and EC submissions, monitoring and all trial-related activities.CRA experience in: Phase IV: neurology (sleep disorder)Phase II / III: cardiology (congestive heart failure), urology (urinary tract infection), oncology (pancreatic cancer, renal cancer, prostate.

Management of production and logistic operations (solid forms)

Management of documentation and compliance departments (injectables / biotechnology)

Clinical production unit, control and release of products for international clinical trials (injectables / biotechnology)

Pharmacist, Pharmaceutical Sciences, Honours

Graduated with Honors Dissertation title: "Immunological hypothesis of photoallergy induced by exogenous agents"

Phd, Pharmaceutical Sciences, Ph.D.

Scientist / Research Supervisor