In-depth knowledge of MDR, EN 13485:2016, and FDA regulations for combination products
Expertise in CAPA formulation, risk management, and internal audits
Proficient in technical documentation review and regulatory compliance for heparin-coated medical devices
Strong track record in process validation and QMS implementation
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Our content and services may vary by location.
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Overview
- Availability
- Asap; 20h/week; on-site & remote
- Qualification
- ---
- Language Skills
- German (Fluent), English (Fluent)
- Relevant Expertise
- Medical Devices, Regulatory Compliance, Audits, CAPA, GAP Analysis, ISO 14791, Tissue Engineering Regulations, ATMPs, Human Tissue Compliance (EU Dir. 2004/23/EC, FDA HCT/P), Biocompatibility (ISO 10993), Good Tissue Practice (GTP), Heparin Coating Compliance, Drug-Device Combination (21 CFR Part 4, EMA Guideline 2019), GMP, Biological Safety Assessment, PMS & Vigilance (ISO 20417), FDA 21 CFR 1271 (Human Cells, Tissues & Tissue-Based Products)
Key-Facts
Extract from Previous Activities
Medical Devices Company, Germany
Person Responsible for Regulatory Compliance
Assumed responsibility as a temporary PRRC, ensuring compliance with regulatory standards for Class I & II devices
Conducted reviews and GAP analyses of technical documentation, emphasizing the integration of heparin coating in the design dossier
Medical Devices Company, Germany
Person Responsible for Regulatory Compliance (MDR)
Temporary assumption of the function of responsible person
Batch Release
Preparation/formulation of CAPA/NC as well as follow-up and monitoring of the measures/mitigations
Review & GAP Analysis: technical documentation, Risk-Management File, Production Processes (IQ/OQ/PQ), Essential Requirements/Safety Requirements
Medical Devices Company, Germany
Regulatory Affairs Expert
Review & GAP Analysis: technical Documentation, Risk-Management File – Update, Production Processes (IQ/OQ/PQ)
Essential Requirements/Safety Requirements Annex I – MDR, “All Over” – Conformity
Medical Devices Company, Germany
Quality Expert
Support for: Quality Management/Regulatory Department, Review & Update Risk-Management File, Conformity Assessment on few documents part of STED, Review/Check Essential Requirements/Safety Requirements
GAP Analysis: QMS EN13485:2016, CRF820, EN 14971, MDSAP
Function: Preparation/formulation of CAPA/NC as well as follow-up and monitoring of the measures/mitigations