Zurich, Zurich, Switzerland
I am a results-driven executive with 20+ years of experience in Quality Assurance and Regulatory Affairs for the medical device industry. As Vice President, Quality & Regulatory Affairs for Europe, the Middle East, Africa, and Asia (EurAsia), I lead regional strategies that drive regulatory success, expand patient access, and ensure full compliance with global standards. My expertise spans a wide range of quality and regulatory frameworks, including MDSAP, ISO 9001, ISO 13485, ISO 17025, CMDR, ISO 14001, MDD, MDR, IVDR, GMP, GDP, J-GMP, FDA, China NMPA, INMETRO, and more. I have a proven track record of managing complex business process changes, fostering cross-functional collaboration, and delivering exceptional results through effective planning and communication. My mission is to advance healthcare and improve patient outcomes by ensuring the highest standards of quality and safety for medical products and services.
Leadership & Reporting: >Reports directly to the Chief Regulatory Officer, with additional dotted-line relationships to the Chief Quality & R&D Officer and the President of EurAsia's commercial business. Strategic Direction: Develops and executes robust Quality and Regulatory (QARA) strategies across Europe, the Middle East, Africa, and Asia, ensuring compliance and alignment with business priorities. Key Responsibilities: > Ensures regulatory compliance, product registration, complaint management, post-market surveillance, and field corrective actions in OUS (Outside US) markets. > Leads and participates in cross-functional and regional leadership teams (Quality Leadership Team, Regulatory Leadership Team, QA Council & RA Council, Business Leadership Team Eurasia). > Manages regulatory submissions, audit preparedness, adverse event reporting, and collaboration with operational partners. > Implements processes and policies to achieve financial and strategic goals. > Engages with global regulators to support commercial plans and influence regulatory trends. > Oversees regional Quality Management Systems (QMS) and ensures compliance with changing regulations. > Champions efficiency, cost reduction, and quality improvement initiatives, leveraging AI, technology, and data analytics. > Optimizes organizational structure and manages QARA talent, focusing on attracting, retaining, and developing high-performing teams. > Strategic and proactive leadership, develop and implement regional QARA strategies and plans that: drive significant improvements and a culture of excellence, are aligned with Regional and Enterprise business strategic priorities, and deliver a Put Patients First culture
RP (Responsible Person) for the wholesale and trade abroad of medicinal products under the scope of Baxter Healthcare SA’s license according to the Swiss Medicinal Products Licensing Ordinance, MPLO (Arzneimittel-Bewilligungsverordnung, AMBV, 812.212.1). Fachtechnisch verantwortliche Person (FvP) UKRP (United Kingdom Responsible Persons) as set out in the UK MDR 2002 from the Medicines and Healthcare Products Regulatory Agency (MHRA) QMR (Quality Management Representative) for Baxter Healthcare SA and other Baxter legal entities. LMR (Legal Manufacturer Representative) for all Baxter Medical devices registered under Baxter Healthcare SA PRRC (Person Responsible for Regulatory Compliance) as required in the frame of the regulation (EU) 2017/745 (EU MDR) for Baxter Healthcare SA labeled products. Ensuring that the general obligations of legal manufacturers as defined in Article 10 of the EU MDR. Define, develop, and lead regional strategies to maximize regulatory and patient success to enable access to meaningful medicines and Medical Devices. Strategic and tactical advice and guidance to Country QA & RA EMEA teams to achieve timely and efficient conduct of development programs while maintaining full compliance with applicable quality and regulatory requirements. Maintenance and update of company recordings in registers of medicinal products, Pharmaceuticals, Generics and Nutrition – Type IA, Type IB, Type II According to EC No 1234/2008 Support and participation on GPx, ISO 13485, ISO 14001, MDD and MDR, MOH (Ministry of Health) Audits. Lead, support and active engagement in implementing of the Medical Device Regulation MDR 2017/745 for Baxter. (tasks: EUDAMED, Economic Operator, Authorized Representative, Importer, Technical file, CER, PSUR, PMCF etc.) Implement the Baxter Corporate Quality Systems including EMEA & local requirements relating to CQA and W&D and other relevant standards - EN ISO 9001, EN ISO 13485, GMP, GDP and country specific requirements.
RP (Responsible Person) for the wholesale and trade abroad of medicinal products under the scope of Baxter Healthcare SA’s license according to the Swiss Medicinal Products Licensing Ordinance, MPLO (Arzneimittel-Bewilligungsverordnung, AMBV, 812.212.1). Fachtechnisch verantwortliche Person (FvP) UKRP (United Kingdom Responsible Persons) on as set out in the UK MDR 2002 from the Medicines and Healthcare products Regulatory Agency (MHRA) QMR (Quality Management Representative) for Baxter Healthcare SA and other Baxter legal entities. LMR (Legal Manufacturer Representative) for all Baxter Medical devices registered under Baxter Healthcare SA PRRC (Person Responsible for Regulatory Compliance) as required in the frame of the regulation (EU) 2017/745 (EU MDR) for Baxter Healthcare SA labelled products. Ensuring that the general obligations of legal manufacturer as defined in Article 10 of the EU MDR. Define, develop and lead regional strategies to maximize regulatory and patient success, to enable access to meaningful medicines and Medical Devices. Strategic and tactical advice and guidance to Country QA & RA EMEA teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable quality and regulatory requirements. Maintenance and update of company recordings in registers of medicinal products, Pharmaceutical, Generics and Nutrition – Type IA, Type IB, Type II According to EC No 1234/2008 Support and participation on GPx, ISO 13485, ISO 14001, MDD and MDR, MOH (Ministry of Health) Audits. Lead, support and active engagement in implementing of the Medical Device Regulation MDR 2017/745 for Baxter. (tasks: EUDAMED, Economic Operator, Authorized Representative, Importer, Technical file, CER, PSUR, PMCF etc.) Implement the Baxter Corporate Quality Systems including EMEA & local requirements relating to CQA and W&D and other relevant standards - EN ISO 9001, EN ISO 13485, GMP, GDP and country specific requirements.
Define, develop and lead regional strategies to maximize regulatory and patient access success to enable access to meaningful medicines and Medical Devices. Strategic and tactical advice and guidance to RA WE teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements. Cross-departmental cooperation including but not limited to R & D, Clinical & Medical Affairs and QM. Monitoring and updating of the relevant standards and coordination of compliance assessment Maintenance and update of company recordings in registers of medicinal products, Pharmaceutical, Generics and Nutrition – Type IA, Type IB, Type II According to EC No 1234/2008 PRRC Person responsible for Regulatory Compliance according to MDR (Medical Device Regulation) Support and participation on GPx, ISO 13485, ISO 14001, MDD and MDR, MOH (Ministry of Health) Audits. Support CAPA in regards Pharmacovigilance activities. Lead, support and active engagement in implementing of the Medical Device Regulation MDR 2017/745 for Baxter. (tasks: EUDAMED, Economic Operator, Authorized Representative, Importer, Technical file, CER, PSUR, PMCF etc.) Baxter focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions. Baxter's BioScience business produces recombinant and blood plasma proteins to treat hemophilia and other bleeding disorders; plasma-based therapies to treat immune deficiencies and other chronic and acute blood-related conditions; products for regenerative medicine, and vaccines. Baxter's Medical Products business produces intravenous products and other products used in the delivery of fluids and drugs to patients; inhalational anaesthetics; contract manufacturing services; and products to treat end-stage renal disease, or irreversible kidney failure, including products for peritoneal dialysis and hemodialysis.
Medical approval for endoscopic equipment for human and veterinary medicine and for industrial applications:, FDA. CE, Japan, Canada, Brasilien many more countries EN ISO 9001 Qualitätsmanagementsystem EN ISO 13485 Qualitätsmanagementsystem für Medizinprodukte CMDR ISO 13485, ISO 9001 the Canadian Medical Devices Regulations ISO 14001 Environmental management MDD 93/42 Annex II of European Medical Device Directives MDR 2017/745 J-GMP Japanese Pharmaceutical Affairs Law FDA Good Manufacturing Practices (GMP) / Quality System (QS) Regulation Part 820 China National Compulsory Certification for Electrical and Electronic Products INMETRO & CERTUSP / NCC Brasil Certification Association
Medizintechnische Zulassungen:, FDA. CE, Japan, Canada, Brasilien und weitere Länder, Produktion-, Managment-& Entwicklungs-Prozess, Projektmanagement, Q-Management, Risikomanagement, in der Medizintechnik. Bekannter Versender (Know consignor) EN ISO 9001:2008 Qualitätsmanagementsystem EN ISO 13485:2012/AC:2012 Qualitätsmanagementsystem für Medizinprodukte CMDR ISO 13485:2003, ISO 9001:2008 the Canadian Medical Devices Regulations ISO 14001:2004/AC2009 Environmental management MDD 93/42 Annex II of European Medical Device Directives J-GMP Japanese Pharmaceutical Affairs Law FDA Good Manufacturing Practices (GMP) / Quality System (QS) Regulation Part 820 China National Compulsory Certification for Electrical and Electronic Products INMETRO & CERTUSP / NCC Brasil Certification Association
Verantwortlicher Qualitätsleiter für alle Produkte und Bereiche. Verantwortlicher für Arbeitssicherheit und Unfallverhütung. Führung von Mitarbeitern. Leitung EDV inklusive Beschaffung, Betreuung, Schulung und Support Erstellung von Prüfplänen und jährlichen Statistiken. Verwaltung des Qualitätsbudgets und des Inventars. Ansprechpartner für alle Lieferanten und Unterakordanten. Qualitätssteigernde Massnahmen erarbeiten und umsetzen. Erstellung der Zertifizierungsunterlagen ISO 9001:2000