07.10.2026 aktualisiert
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Head of Regulatory Affairs & Quality Management | Medical Devices
Romanshorn, Schweiz
Romanshorn +250 km
M.Sc. Quality Management, Hochschule Wismar (2014-2016)Über mich
Über 10 Jahre Erfahrung im Qualitätsmanagement und Regulatory Affairs der Medizintechnik. Experte für ISO 13485, MDR, FDA, MDSAP, Audits, CAPA, Risikomanagement, Technische Dokumentation und globale Zulassungen.
Skills
Medizinische GeräteDevice ManagementQualitätsmanagementProzess ManagementRichtlinie für MedizinprodukteAufbereitung von MedizinproduktenGerätequalifizierungRegulatory Affairs
Regulatory Affairs Management
Worldwide registration of medical devices including CE (MDD/MDR), Japan, Canada, Australia and USA (510(K)). Extensive experience in creation and maintenance of technical files for medical devices of classes I, IIa and IIb, as well as implementation of MDR requirements.
Quality Management Systems
Eight years of experience as Quality Management Representative. Successful implementation of EN ISO 13485:2016 and MDSAP requirements (Canada, Australia, USA and Japan) in various companies. Integration and implementation of CAPA and change management processes.
Process Validation & GxP
Successful process validations, equipment qualifications and measurement equipment analysis (GxP). Expertise in cleaning validation within manufacturing processes of medical devices and calculating measurement uncertainty.
Standards Expertise
Deep knowledge of EN ISO 13485, EN ISO 9001, EN ISO 14971, EN ISO 10993-1, EN ISO 17664-1, EN ISO 11137-1, EN ISO 19011 and EN ISO 11607-x.
Medical Device Portfolio
Experience with active medical devices (ventilators, light therapy devices, vitrectomy cutters), surgery devices (single use sterile and reusable I/A systems) and medical textile devices (compression stockings).
Technical Documentation
Creation of technical files according to MDR and MDD. Specialist experience in technical documentation for medical devices at Bioptron AG.
Team Leadership
Leadership and management of a seven-member laboratory team. Experience in heading regulatory affairs and quality management departments across multiple organizations.
FDA Audit Preparation
Certified preparation for FDA Audit. Supporting experience for 510(K) registration in the USA.
Worldwide registration of medical devices including CE (MDD/MDR), Japan, Canada, Australia and USA (510(K)). Extensive experience in creation and maintenance of technical files for medical devices of classes I, IIa and IIb, as well as implementation of MDR requirements.
Quality Management Systems
Eight years of experience as Quality Management Representative. Successful implementation of EN ISO 13485:2016 and MDSAP requirements (Canada, Australia, USA and Japan) in various companies. Integration and implementation of CAPA and change management processes.
Process Validation & GxP
Successful process validations, equipment qualifications and measurement equipment analysis (GxP). Expertise in cleaning validation within manufacturing processes of medical devices and calculating measurement uncertainty.
Standards Expertise
Deep knowledge of EN ISO 13485, EN ISO 9001, EN ISO 14971, EN ISO 10993-1, EN ISO 17664-1, EN ISO 11137-1, EN ISO 19011 and EN ISO 11607-x.
Medical Device Portfolio
Experience with active medical devices (ventilators, light therapy devices, vitrectomy cutters), surgery devices (single use sterile and reusable I/A systems) and medical textile devices (compression stockings).
Technical Documentation
Creation of technical files according to MDR and MDD. Specialist experience in technical documentation for medical devices at Bioptron AG.
Team Leadership
Leadership and management of a seven-member laboratory team. Experience in heading regulatory affairs and quality management departments across multiple organizations.
FDA Audit Preparation
Certified preparation for FDA Audit. Supporting experience for 510(K) registration in the USA.
Sprachen
DeutschverhandlungssicherEnglischverhandlungssicher
Projekthistorie
Leading regulatory affairs and quality management at SIGVARIS AG since February 2022.
Director of Global Regulatory Affairs and Quality at SIGVARIS GROUP, responsible for global regulatory strategy and quality management.
Responsible for regulatory affairs and quality management across both Buerki inno med AG and SteriMed Tec AG.