31.10.2025 aktualisiert
100 % verfügbar
Senior Regulatory Affairs and Quality Management Consultant
Hamburg, Deutschland PhD in Molecular Biology
Skills
SoftwareanwendungenKlinische ArbeitenKlinische BewertungComplianceDestillationPharmakovigilanzIso 13485InstandhaltungMeddraQualitätsmanagementFernüberwachungTechnische DokumentationPubmedMedizinsches MaterialRegulatory AffairsRisikomanagement
Regulatory Compliance Management
Expertise in developing regulatory compliance strategies under MDR, ISO 13485, and global standards with over 15 years of experience in the medical device industry.
Regulatory Submissions
Regulatory submissions expertise across EU, USA, Asia, South America, and North Africa markets
Quality Management Systems
Certified Auditor for ISO 13485 and TÜV SÜD Partner with expertise in Quality Management Systems (QMS) development and audit execution for active and non-active medical devices.
Technical Documentation
Experienced in creating and maintaining Technical Documentation for Class IIa, IIb, and III medical devices
Clinical Evaluations and PMCF
Preparation of Clinical Evaluation Reports and Post-Market Clinical Follow-up activities for various medical device classes.
Risk Management and Post-Market Surveillance
Hands-on experience in risk management, post-market surveillance, and technical documentation for medical devices across multiple regulatory regions
Regulatory Tools Proficiency
EUDRAMED, EMBASE, PubMed/MEDLINE, MedDRA regulatory tools expertise
Software Applications
Track-wise, Distiller SR, MS Office suite including Excel and PowerPoint proficiency
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicherKroatischMuttersprache
Projekthistorie
Certified Auditor for QMS under ISO 13485 and active medical devices in partnership with TUV SUD. External PRRC and quality management responsible person for global clients. Leading projects in regulatory compliance, clinical affairs, vigilance and quality management for Class I, IIa, and IIb and III devices.
Designed clinical strategies for ventilation therapy and anesthesia devices. Authored CERs and conducted PMCF activities in alignment with MDR and MDCG guidelines. Developed global SOPs for Clinical Evaluations and PMCF, ensuring streamlined compliance across international markets.
Directed pharmacovigilance programs, including PSURs, risk management, and FDA inspections. Oversaw post-market surveillance and risk management for Class IIa and IIb medical devices. Conducted CAPAs, audits, and risk assessments based on ISO 14971 and MDD requirements.