CV

About me

As a company success focused leader with over 15 years of experience overseeing all aspects of quality and regulatory affairs compliance management, team leadership, P&L responsibiltiy and relationship building within a fast-paced environment of Pharma and Medical Devices including Software and AI (Digital Health).

Proud leader of the QARA team achieving of EU MDR Class IIb and US FDA 510(k) for Huma as disease agnostic remote patient monitoring solution with AI and algorithms built in, for pediatrics and adults in less than a year.

Leveraging my strong communication and organizational skills. I am instrumental in establishing long-lasting relationships with key stakeholders, boards, business professionals, and organizational and operation management to create and ensure real-time organizational success.

Throughout my leadership roles, I played a critical role in company growth by devising and implementing effective strategies while providing excellent services to existing and new clients with quick and easy market access. To secure future business of the company, I am adept at working closely with business partners and key shareholders. Along with this, I am expert in ensuring operational execution while complying with all rules and regulations of the company.

Utilizing my strong work motivation, I am dedicated to overseeing development and submission of all regulatory applications to the FDA, EU, MDSAP and other international regulatory bodies and supporting authorities in finding the right balance between industry support and regulatory safety and efficency. Furthermore, I am committed to supervising managers while assessing overall departmental performance to achieve performance goals for the seamless running of business operations. I am a strong multilingual with expertise in English and German.

Core competencies

Quality Assurance and Regulatory Affairs Compliance - MedDev, IVD, Pharma
Project Management with Lean principles
Budget Preparation, P&L & Allocation
Business Development & Growth
Strategic Planning & Implementation
Innovation & Creativity
Team Building & Leadership
Operational Excellence
Conflict Management
Cross-functional Collaboration

Experience

Heading regulatory for market leading IVD manufacturer

Currently leading regulatory affairs for all products manufactured in Siemens Healthineers’ Marburg site. Overseeing worldwide registrations, ensuring compliance across diverse international markets, and driving regulatory strategies for a wide portfolio of healthcare products.

Founder and Managing Director: Specialized Quality and Regulatory Consultancy, contract legal manufacturer for AI and SaMD

Founded ADHOCON, an ISO13485:2016 certified Contract Legal Manufacturer specializing in AI and Software as Medical Devices. I manage all key regulatory and quality processes, ensuring compliance for medical devices across 132 countries, while providing expert consultancy in quality and regulatory affairs.

Global Director: Quality and Regulatory Affairs in Digital Health

Led the global quality and regulatory team at HUMA Therapeutics, achieving EU MDR Class IIb and US FDA 510(k) certifications for AI-based software solutions in record time. Played a key role in business growth by securing compliance and regulatory submissions worldwide.

Senior Director: Quality & Regulatory Compliance for Global Operations

At Getinge Group, I directed the quality and regulatory compliance functions across sales and service regions, managing product registrations in over 130 countries. Successfully implemented Lean Six Sigma projects, streamlined complaint management, and optimized regulatory processes.

Director of Quality: Pharmaceutical Development and Clinical Trials

Led quality assurance teams at Merck Group, ensuring regulatory compliance for clinical trials and pharmaceutical development. Spearheaded efforts to optimize transitions from R&D to commercial production, securing approvals from authorities such as the US FDA.

Quality Leadership: Managing Compliance and Manufacturing in Pharma

Oversaw manufacturing and quality compliance for prescription drugs at Warner Chilcott/Procter & Gamble and Reckitt Benckiser. Led GMP compliance, handled batch approvals, and ensured regulatory adherence across multiple product lines.

R&D and CMC Manager: Early Development of Monoclonal Antibodies

Led early-phase R&D and CMC development for monoclonal antibodies in Phase I and IIa clinical trials at Abbott/Abbvie, focusing on process development, optimization, and clinical supply management.

My values

I am driven by a commitment to excellence, ensuring that innovation and regulatory compliance go hand in hand to deliver impactful solutions in the pharmaceutical and medical device industries. I believe in leadership through collaboration, fostering growth and success across global teams, while upholding the highest standards of quality and integrity in everything I do.