Freelancer profile translated to English.

Description

You develop molecular IVD assays and need someone who knows how to get them through FDA and IVDR? That's exactly what I do.

I guide IVD companies from the Analytical Performance Strategy to successful market approval. With over 11 years at Roche Diagnostics, I've learned what regulators really need and how to build a development program that is scientifically sound, regulatorily justifiable, and operationally feasible.

Typical projects: Building APV strategies for new assays, assessing precedent devices, study program design for FDA 510(k) and IVDR, Technical Project Lead for complex multiplex assay developments.

Reference projects: CE marking cobas EBV in 16 months, FDA clearance 5 months ahead of schedule, SARS-CoV-2 assay in 6 weeks, Technical Project Lead for cobas Respiratory Flex, Roche's first 15-channel multiplex assay.

Available remotely and on-site, in German, English, or Japanese.

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 (2 months)
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