Senior Quality, Regulatory & Compliance Consultant for Medical Devices | ISO 13485, EU MDR, FDA, Risk Management & Supplier Compliance
I am the founder of DINCON Consulting and a senior Quality, Regulatory and Compliance Consultant with 24 years of professional experience, including 16 years in the medical device industry and 8 years in the automotive sector.
I support medical device manufacturers, suppliers and consulting partners with practical, audit-ready solutions in Quality Management, Regulatory Affairs, Risk Management, Complaint Handling, Post-Market Surveillance, Validation, CAPA, Nonconformity Management and MDR/FDA compliance.
My expertise covers ISO 13485, EU MDR 2017/745, ISO 14971, ISO 9001, FDA requirements, supplier qualification, process validation, technical documentation remediation and quality system optimization.
I have worked with Class I, IIa, IIb and III medical devices, including active medical devices, and have supported companies in preparing for audits, improving QMS processes, handling complaints and nonconformities, and closing compliance gaps efficiently.
DINCON Consulting focuses on structured, pragmatic and business-oriented compliance support. My goal is not only to create documentation, but to build processes that are understandable, maintainable and audit-ready.
I am especially interested in freelance, project-based and interim consulting opportunities in Switzerland, Germany and the EU.
Work Terms
I am available for remote, hybrid and on-site consulting assignments, especially in Switzerland, Germany and the EU.
Preferred engagement types include freelance projects, interim quality/regulatory management, audit preparation, documentation review, process improvement, supplier qualification and remediation projects.
Communication can be conducted in English, German or Turkish.
Payment terms and project milestones can be agreed individually depending on project scope, duration and urgency.
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