Heinz Stucki

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.

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

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