16.04.2026 aktualisiert
100 % verfügbar
Senior Project Manager - Medical Device & Pharmaceutical Environments
Ingolstadt, Deutschland
Nur Remote
Bachelor of Science Medical EngineeringÜber mich
Project Manager with 7+ years leading cross-functional projects in regulated medical device and pharmaceutical environments. Experienced across full lifecycle from development to production. Strong background in GMP, ISO 13485, MDR, FDA, risk management and validation.
Skills
GerätequalifizierungGmp-gerechte DokumentationInbetriebnahme
Project Management in Regulated Environments
Comprehensive project management expertise in GMP, ISO 13485, MDR, and FDA-regulated medical device and pharmaceutical environments with end-to-end project leadership capabilities
Validation and Verification Management
Advanced validation planning and verification processes including IQ/OQ/PQ protocols, risk management according to ISO 14971 and FMEA methodologies
Regulatory Compliance and Quality Assurance
Deep knowledge of MDR regulation, GMP compliance, CAPA processes, and regulatory requirements with hands-on experience in audit coordination and compliance management
Equipment Qualification
Specialized expertise in equipment qualification processes and validation protocols for medical device manufacturing environments
SOP Creation and Documentation
Proficient in creating standard operating procedures and maintaining comprehensive technical documentation for regulated environments
Risk Analysis and Management
Advanced risk analysis capabilities with experience in risk register management and mitigation strategies
Cross-functional Team Leadership
Proven ability to lead and coordinate cross-functional teams across QA, R&D, Manufacturing, Engineering, and IT departments
C++ Programming
Programming skills in C++ language for technical applications and system development
CAD Design
Technical design capabilities using CAD Creo 4.0 for engineering and product development applications
Comprehensive project management expertise in GMP, ISO 13485, MDR, and FDA-regulated medical device and pharmaceutical environments with end-to-end project leadership capabilities
Validation and Verification Management
Advanced validation planning and verification processes including IQ/OQ/PQ protocols, risk management according to ISO 14971 and FMEA methodologies
Regulatory Compliance and Quality Assurance
Deep knowledge of MDR regulation, GMP compliance, CAPA processes, and regulatory requirements with hands-on experience in audit coordination and compliance management
Equipment Qualification
Specialized expertise in equipment qualification processes and validation protocols for medical device manufacturing environments
SOP Creation and Documentation
Proficient in creating standard operating procedures and maintaining comprehensive technical documentation for regulated environments
Risk Analysis and Management
Advanced risk analysis capabilities with experience in risk register management and mitigation strategies
Cross-functional Team Leadership
Proven ability to lead and coordinate cross-functional teams across QA, R&D, Manufacturing, Engineering, and IT departments
C++ Programming
Programming skills in C++ language for technical applications and system development
CAD Design
Technical design capabilities using CAD Creo 4.0 for engineering and product development applications
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2026
Sprachen
DeutschMutterspracheEnglischMutterspracheHebräischMuttersprache
Projekthistorie
Lead and manage regulated development and validation projects for pharmaceutical and medical device environments. Manage cross-functional teams and ensure project execution in compliance with GMP, ISO 13485, MDR, and FDA requirements.
Led Class III invasive medical device R&D and lifecycle management. Acted as technical project coordinator for product improvements and managed cross-functional activities across R&D, QA, Manufacturing, and Regulatory Affairs.
Designed and built test systems for invasive blood pressure devices and executed verification and conformity testing on Class II pressure transducers.