Senior Medical Device Risk Management Consultant – FDA QMSR Readiness

Project overview

For our medical technology client, we are looking for a Senior Medical Device Risk Management Consultant – FDA QMSR Readiness on a freelance basis (100% Remote). The position is initially full-time until March 31, 2027 (with an option for extension).

In this role, you will independently evaluate the existing risk management system (ISO 14971) and its practical implementation at selected pilot sites.

We look forward to your application!

Skills

• Current-State & FDA QMSR Readiness Assessment: Independent evaluation of existing risk management processes, SOPs, and documentation across the entire product lifecycle (Design, Manufacturing, Post-Market) to determine audit readiness for FDA inspections.
• Prioritized Gap Analysis & Roadmap: Creation of a well-founded assessment report with clear priorities, responsibilities, and action steps for internal implementation.
• Method Development & End-to-End Harmonization: Definition of a consistent link between Hazard Analysis, Design FMEA, Application FMEA, Software FMEA, and Process FMEA.
• Tool & Template Optimization: Development of configuration recommendations for risk management IT tools, revision of FMEA standards, and integration of risk-based statistical methods.
• Post-Market Risk Assessment: Update of relevant templates and processes for Health Hazard Evaluations (HHE), Defect Risk Assessments, and product deviations.
• Knowledge Transfer & Management Summary: Preparation of results, lessons learned, and strategic recommendations for the company-wide roll-out.
• 100% Remote (occasional on-site workshops in Bad Homburg)
• Industry & Consulting Experience: Several years of demonstrable experience in risk management transformations and compliance projects in the medical technology sector.
• Regulatory Expertise: In-depth knowledge of FDA requirements – especially the new FDA QMSR (21 CFR Part 820) – as well as ISO 14971 and ISO 13485.
• Product-Specific Know-how: Practical risk management experience with both active medical devices and disposables.
• Method & Tool Competence: Mastery of modern FMEA landscapes, tool-supported risk management systems, and evidence-based statistical control methods.
• Post-Market Competence: Routine in the assessment and design of Health Hazard Evaluations (HHE) and defect analyses.
• Presentation & Consulting Competence: Strong ability to communicate complex issues and methodology recommendations in a management-friendly manner.
• Language Skills: Fluent German and English, both written and spoken.

Project details

• Start: 04.11.2026
• Duration: 31.03.2027
• Remote: remote
• Location: 61352 Bad Homburg vor der Höhe, DE
• Languages: German