19.01.2026 aktualisiert
100 % verfügbar
Regulatory Affairs Manager & Project Manager Life Science Consulting
Eschweiler, Deutschland
Nur Remote
M.Sc. in BiologySkills
ForschungAuditsBiologieKorrektur- und VorbeugemaßnahmeKrankenaktenKlinische ArbeitenKlinische BewertungKlinische ForschungComplianceBeratungEhealthGute Klinische PraxisIso 13485ISO 14971Instandhaltung
Regulatory Affairs and Clinical Documentation
Expertise in clinical evaluations, technical documentation, PMCF studies, complaint management and MDR submissions with over 10 years of experience in the life sciences industry
Medical Device Compliance
Proven expertise in medical devices Class I-III with 6 years of experience, including MDR/IVDR compliance, FDA CFR, ICH-GCP, ISO 13485, and ISO 14971 standards
Quality Management and Project Leadership
Successfully led international, multicenter projects with focus on regulatory compliance, stakeholder communication, and quality management including audit preparation
Technical Documentation
EU MDR 2017/745, MDD, IVDR compliant documentation creation and maintenance
Clinical Evaluation and Investigation
MEDDEV 2.7/1 Rev. 4, ISO 14155 compliant clinical studies and evaluations
Medical Writing
CEP, CER, PMCF, CSRs authoring and regulatory document creation
Post-Market Surveillance
PMCF strategy development and implementation
CAPA and Complaint Management
NC/CAPA Coordinator experience with SAP-based processing
DiGA Authorization
Software verification and digital health application authorization processes
Expertise in clinical evaluations, technical documentation, PMCF studies, complaint management and MDR submissions with over 10 years of experience in the life sciences industry
Medical Device Compliance
Proven expertise in medical devices Class I-III with 6 years of experience, including MDR/IVDR compliance, FDA CFR, ICH-GCP, ISO 13485, and ISO 14971 standards
Quality Management and Project Leadership
Successfully led international, multicenter projects with focus on regulatory compliance, stakeholder communication, and quality management including audit preparation
Technical Documentation
EU MDR 2017/745, MDD, IVDR compliant documentation creation and maintenance
Clinical Evaluation and Investigation
MEDDEV 2.7/1 Rev. 4, ISO 14155 compliant clinical studies and evaluations
Medical Writing
CEP, CER, PMCF, CSRs authoring and regulatory document creation
Post-Market Surveillance
PMCF strategy development and implementation
CAPA and Complaint Management
NC/CAPA Coordinator experience with SAP-based processing
DiGA Authorization
Software verification and digital health application authorization processes
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2021
Sprachen
DeutschMutterspracheEnglischverhandlungssicherRussischMuttersprache
Projekthistorie
Led hands-on coordination of complaint handling process from intake to closure for custom products. Assigned tasks to cross-functional teams including Batch Record, Regulatory Affairs, Investigation, Risk Assessment and Quality.
Created and updated Clinical Evaluation Plans and Clinical Evaluation Reports in compliance with EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4. Served as key regulatory contact for clinical documentation and supported Post-Market Clinical Follow-up activities.
Independently compiled and maintained documentation and assessment reports in accordance with EU MDR requirements. Created Clinical Evaluation Plans and Clinical Evaluation Reports, conducted comprehensive literature searches and data analysis.