11/02/2023 updated

**** ******** ****
80 % partially available

GxP-regulated industries specialist ― Regulatory Affairs & Q (QA/RA), R&D, RM, Program Management

Girne, Cyprus
Only remote
B.A. (Philosophy, Political Science, Computer Science)
Girne, Cyprus
Only remote
B.A. (Philosophy, Political Science, Computer Science)

Title 21 of the Code of Federal RegulationsUser Experience (UX)ResearchAgile MethodologyArchitectureAutomationBusiness IntelligenceBiologyMedical ImagingHealth InformaticsISO 9000Business ContinuityBusiness Process ImprovementGood Manufacturing PracticesCorrective and Preventive Action (CAPA)Clinical WorksClinical TrialsClinical Trial Management SystemsCapability Maturity Model IntegrationControl Objectives for Information and Related Technology (COBIT)Computer SecurityConsultingScientific Data ArchivingProject PlanningDicomDocument Management SystemsDigitizationDisaster RecoveryDynamic Systems Development MethodsElectronic Common Technical DocumentRecords ManagementEnterprise Resource PlanningEnvironmental ComplianceErgonomicsElectronic SignaturesFailure Mode Effects AnalysisFailure Mode Effects and Criticality AnalysisFood SafetyGovernanceGovernance Risk Management and ComplianceHazard and Operability StudyHealth CareHealth Insurance Portability and Accountability Act (HIPAA) ComplianceInformation Technology Infrastructure Libraries (ITIL)Enterprise ArchitectureIT ManagementISO 13485ISO 14971Laboratory Information Management SystemsMachineryMaintenanceManagement SystemsProject ManagementScrum MethodologyProduction LineSystems Development Life CycleQuality ManagementResearch and DevelopmentTransition ManagementMedicomRequirements ManagementRisk AnalysisRobotics Design and ProductionRestriction of Hazardous Substances DirectiveSarbanes-Oxley Act (SOX) ComplianceUsability TestingVulnerability AssessmentWorkflowsWorkflow Management SystemsProcess ManagementMedical Device DirectiveReliabilityData ProtectionTogafInformation TechnologyMedical MaterialRegulatory AffairsRisk ManagementPacs
Specializing in GxP Regulated Industries (Medical Devices, Life Sciences) in the fields of

Quality & Regulatory Affairs Management
Program & (Multi-)Project Management
Requirements Management
Digital Transformation Consulting & Management
Organizational Excellence, Governance/Risk/Compliance, Transition Management
Enterprise IT Management for Regulated Industries / Healthcare


Quality & Regulatory Affairs Management:
  • Regulatory expertise for: USA (FDA), Canada (Health Canada), European Union (Notified Bodies), China (CFDA), Japan (PMDA), Brazil (ANVISA), Mexico (COFEPRIS), Australia (TGA)
  • 21 CFR Part 820 (QSR, cGMP, PHA, FMEA, CAPA, HHA, PDCA cycle)
  • 21 CFR Part 11 (Electronic Records and Electronic Signatures)
  • FDA Q9 QRM (PHA, FMEA, FMECA, FTA, HACCP, HAZOP)
  • 21 CFR Part 808 (Device Exemptions)
  • 21 CFR Part 812 (Clinical Investigations)
  • GAMP5, Computer Systems Validation (CSV), SDLC, SOPs
  • Validation Process Management (Project Plan, VMP, Design Transfer, DQ, PQ, IQ, OQ)
  • Validation Master Plan (VMP) creation, maintenance, management
  • System Reliability & Risk Analysis (Design/Functional/Process FMEA & FMECA)
  • Design Transfer QA, Management, Execution, QA-support for Operations setup
  • 510(k) Clearance (Pre-market Notification)
  • ISO 9001 (QS continuous improvement process)
  • ISO 13485 (EU/ECC QSR)
  • ISO 14971 (Risk Management for Medical Devices)
  • ISO 62304 (Medical Device Software SLC)
  • ISO 62366 (Application of usability engineering to medical devices)
  • MDD 93/42/EEC (EU Medical Device Directive)
  • IVD 98/79/EC (EU In Vitro Diagnostic Medical Device Directive)
  • AIMDD 90/385/EEC (EU Active Implantable Medical Device Directive)
  • EU Medical Products Application (EudraLex Vol. 2)
  • EU Medical Products Guidelines (EudraLex Vol. 3)
  • EU GMP (EudraLex Vol. 4)
  • EU Clinical Trials (EudraLex Vol. 10)
  • ICH Q7 (GMP), ICH Q9 (QRM)
  • EU Machinery Directive (2006/42/EC) (application to, and compliance of, machinery which is part of, used by, or together with medical devices, e.g. automated/robotic lab systems)
  • Environmental Compliance of (medical) devices: RoHS (2002/95/EC), REACH (EC No 1907/2006), WEEE (2002/96/EC)
  • Production line inspection & validation (VP, DQ, PQ, IQ, OQ)
  • Planning, inspection, validation of CIP/WIP/SIP procedures, qualification (QC) of equipment
  • HIS, RIS, Medical Imaging / PACS (systems, architecture, implementation)
  • Laboratory Information & Management Systems (e.g. AQ Manager, CareLIMS, LabWare, SLIMS)
  • Clinical IT Infrastructure (architecture, design, implementation, operation, continuity)
  • Clinical IT Security, Threat & Vulnerability Assessment/ Analysis/ Remediation
  • Clinical ERP (IS/H, i.s.h.med)
  • Healthcare IT Standards (DICOM, HL-7, MEDICOM, IHE, ACC, NEMA, RSNA, HIMSS, etc.)
  • Inter-/cross-modality communication & integration (CR, CT, DX, MR, NM, PT, PX, ST, US, XA, etc.)
  • Clinical Workflows
  • Clinical Trials (CTMS, EHR4CR, ICE), Document Management (eCTD), Data Archiving (cDWH)
  • Device ergonomics & UX/usability of clinical applications
  • EHR & Health Information Privacy (HIPAA, HITECH Act, Directive 2011/24/EU)
  • Business Continuity, Disaster Recovery Planning, SOX-404 Compliance in the Healthcare industry

Organizational Excellence, Governance, Strategy, Transition Management:
  • QA/RA Strategy, Implementation, Execution
  • Process Alignment & Coherence
  • Business Continuity
  • Disaster Recovery Planning
  • Enterprise Architecture (TOGAF, CoBIT, CMMI, ITIL)

International Program & Multi-Project Management:
  • Agile (DSDM, Scrum, general theory & application of agile methodologies)
  • PMI/PMBoK
  • Classic (V, Waterfall)

Enterprise IT Management for Regulated Industries / Healthcare:
  • IT Management for Production/Operations & Enterprise Platforms
  • Business Intelligence
  • Compliant Document Management Systems (EHR, HIPAA)
  • Compliant Workflow Management Systems

Experience

Professional experience10+ years
Freelancer since2003

Languages

GermanNative speakerEnglishNative speakerSpanishBasic knowledge

Project history

Medical Devices Quality & Regulatory (QA/RA) / GRC / Cyber Security Consultant

Pharmaceuticals & Medical Technology

GRC (Governance/Risk/Compliance), QA/RA (Quality Assurance / Regulatory Affairs), CS (Cyber Security) – Submission of documents for registration of Medical Devices & Regulatory Requirements / Best Practice

Technologies / Methods:
ISO 13485 / 14971 / 60601 / 61010 / 62304 / 62366 / 27xxx, IEC 80001, 21 CFR, GxP, ISO 27xxx, EN 14683, FDA De Novo Guidance, FDA Cyber Security Guidance, NIST CS Framework, NIOSH Guidance, Agile, Scrum, Kanban, SAFe, DevSecOps Best Practice, Requirements Engineering & Management, Risk Management, FMEA, Cloud Governance Framework

PLEASE SEE MY RESUME FOR DETAILS – ASSIGNMENT #29

Digital Transformation & New Technologies Consultant

Internet & IT

Digital Transformation – Digital Culture, New Work, Enterprise 4.0, Customer & User Experience, IoT, Robotics, Industry 4.0, Factory Automation, Big Data, Cloud, Cyber Security

Technologies / Methods:
OST, Unconference, FooCamp/BarCamp-style, World Cafe, BoF, Agile, Scrum, Kanban, Design Thinking, Design Sprint, ADKAR®, Risk Management, FMEA, applied best practices & standards (e.g. ISO 27xxx, BSI)

PLEASE SEE MY RESUME FOR DETAILS – ASSIGNMENT #28

Global Program Manager ― Digital Transformation & Cloud Solutions

Pharmaceuticals & Medical Technology

Connectivity Solutions for Medical Devices and SaMD – Equipment Controllers, MDDS, IoT, Automation, Cloud

Technologies / Methods:
Agile, Scrum, Kanban, SAFe, ADKAR®, Risk Management, FMEA, ISO 13485 / 14971 / 60601 / 61010 / 62304 / 62366 / 27xxx, IEC 80001, 21 CFR, GxP

PLEASE SEE MY RESUME FOR DETAILS – ASSIGNMENT #27

Quality Manager – Medical Devices R&D

Quality Management & Quality Assurance – Medical Devices R&D

Technologies / Methods:
21 CFR Parts 11, 820, 808, 812, GxP, ISO 13485 / 14971 / 62304 / 62366, MDD, IVD, Risk Management

PLEASE SEE MY RESUME FOR DETAILS – ASSIGNMENT #25

Quality Manager – Medical Devices R&D

Quality Management & Quality Assurance – Medical Devices R&D

Technologies / Methods:
21 CFR Parts 11, 820, 808, 812, 3.2e, 4, GxP, ISO 13485 / 14971 / 62304 / 62366, Scrum, Kanban, SAFe, Risk Management, FMEA, MDD/MDR, IVD, CDx

PLEASE SEE MY RESUME FOR DETAILS – ASSIGNMENT #24

FOR PREVIOUS ASSIGNMENTS, PLEASE REFER TO MY DETAILED RESUME

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