Many Years of experience in Medical Devices with a strong background in DHF Remediation Management
Furthermore, this candidate brings a solid experience in regulatory requirements and has recently terminated a MDR project with Success
K-Recruiting has already successfully collaborated with this candidate and our clients highlighted not only his expertise but also his personal strengths and skills
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Dipl. Eng. & MBA
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- DHF Remediation, DHF Creation, DHF Review, Technical Documentation, Risk Management, CAPA Management, Project Management, Process Optimization, MDR, FDA, SOPs, ISO 13485, ISO 14971, Medical Devices
Key-Facts
Extract from previous activities
Medical Device Company, Germany
MDR Consultant
Implementation of MDR requirements across internal procedures
Defined and implemented new internal Product Development Procedure to meet latest regulations (MDSAP, MDR, ISO 13485:2016, 21 CFR 820)
Definition and implementation of a new internal Risk Management Procedure according to ISO 14971: 2007 and EN ISO 14971:2012
Support of international regulatory (re-)submission documentation across all product lines
Risk management file remediation across all products
Medical Device Company, Germany
DHF Remediation Manager
Project Management: Oversee DHF-related projects, including timelines, budgets, and resources
Lead DHF remediation for medical devices
Develop and execute a comprehensive remediation plan in collaboration with cross-functional teams
Review and assess current DHFs for completeness and accuracy, and identify gaps and deficiencies
Develop and implement strategies to close identified gaps and deficiencies in the DHFs
Continuously monitor and improve DHF processes
Ensure FDA and industry standard compliance
Collaborate to identify root causes and implement CAPA for DHF improvements
Provide status updates to senior leadership
Manage resources, timelines, and budgets associated with the DHF remediation efforts
Ensure DHF remediation documentation is accurate, complete, and compliant
Medical Device Company, Germany
Design and DHF Engineer
Design History File remediation for develop. projects
Remediation planning and management with a dedicated cross-functional core and support teams
Develop FDA-compliant Design History Files and Device Master Records for legacy products from scratch
Monitor and improve DHF processes
Completion of design documentation
Execution of design and process changes
Verification test planning, execution, reporting
Risk management according to ISO 14971
Define and complete CAPAs and non-conformities
Medical Device Company, Germany
DHF Manager
DHF Creation
Conduct assessments of DHFs
Identification of gaps and deficiencies
CAPA Management
Risk Management
SOPs, Technical Documentation
Collaborate with engineering, quality, regulatory, and operations teams to ensure compliance with FDA regulations and industry standards