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 within 307 days from start to certification.

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.

Reviewer Keywords

ai ai and robotics in healthcare medical device medical device legislation medical devices medical device technology medical device technology development and assessment publications quality quality and accreditation quality assessment quality assessment in healthcare regulation regulations regulatory framework regulatory frameworks software standards standards of quality submission