Description

Sie entwickeln molekularbiologische IVD-Assays und brauchen jemanden der weiss wie man sie durch FDA und IVDR bringt? Genau das ist meine Arbeit.

Ich begleite IVD-Unternehmen von der Analytical Performance Strategie bis zur erfolgreichen Marktzulassung. Mit über 11 Jahren bei Roche Diagnostics habe ich gelernt, was Regulatoren wirklich brauchen und wie man ein Entwicklungsprogramm so aufbaut, dass es wissenschaftlich solide, regulatorisch vertretbar und operativ machbar ist.

Typische Projekte: Aufbau von APV-Strategien für neue Assays, Bewertung von Precedent Devices, Studienprogramm-Design für FDA 510(k) und IVDR, Technical Project Lead für komplexe Multiplex-Assay-Entwicklungen.

Referenzprojekte: CE-Markierung cobas EBV in 16 Monaten, FDA-Clearance 5 Monate vor Plan, SARS-CoV-2-Assay in 6 Wochen, Technical Project Lead cobas Respiratory Flex als erstem 15-Kanal-Multiplex-Assay von Roche.

Verfügbar remote und vor Ort, auf Deutsch, Englisch oder Japanisch.

Industry field of expertise

Languages

German
Native or bilingual
English
Fluent
Japanese
Fluent
French
Conversational
Spanish
Basic

Workplace preferences

Can work on-site

Lachen SZ (up to 50km), Basel (up to 40km)

TIB MOLBIOL
Independent IVD Regulatory Consultant (FDA & IVDR)
PHARMACEUTICALS INDUSTRY
June 2026 - Today (1 month)
Berlin, Germany
Advising on IVDR and FDA analytical performance strategy for PCR-based molecular diagnostic assays. Developing analytical performance concepts, study designs and associated documentation for FDA 510(k) and IVDR submissions. Key focus: analytical performance verification, precedent device assessment and study program design for quantitative molecular diagnostics.
Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) Regulatory Strategy Molecular Diagnostics Analytical Performance Verification Strategy Product Development
Roche Diagnostics International AG,
Sub-Chapter Lead in PCR Assay Development
PHARMACEUTICALS INDUSTRY
April 2022 - September 2024 (2 years and 5 months)
Rotkreuz, ZG, Switzerland
Acted as a bridge between science, people, and leadership – balancing technical excellence with human connection
• Led an international cross-functional team in the development of an innovative PCR-based diagnostics product
• Fostered a culture of psychological safety, trust, and continuous learning, empowering team members to take ownership and grow
• Mentored and coached emerging leaders, supporting personal development through structured feedback and individual reflection
• Guided a newly formed team through a successful transformation into a self-organized, high-performing unit
• Successful launches: cobas® HDV RUO and cobas® Respiratory flex
Leadership Development Coaching and mentoring Product Development Team Building Cross-functional Team Leadership
Roche Diagnostics Kabushiki Kaisha (RDKK),
Express Development Opportunity Affiliate Marketing Japan
PHARMACEUTICALS INDUSTRY
October 2023 - January 2024 (3 months)
Tokyo, Japan
Self-initiated rotation to gain experience in affiliate marketing and deepen cultural and strategic understanding of the Japanese market
• Planned and executed pre-marketing activities for an innovative diagnostics product in close collaboration with local stakeholders
• Presented new technology to Japanese customers, gathered market-specific feedback, and translated insights into product positioning strategy
• Developed a strategic roadmap to prepare the launch – balancing global goals with local needs
• Strengthened intercultural communication and built trust in a new cultural context through adaptability, humility, and openness
Intercultural Communication Cross-functional Team Leadership Marketing Strategy Affiliate Marketing Japanese