Thought Leader Digital Health with AI, Quality & Regulatory Compliance | EN ISO 17024 certified expert for AI and Medical Devices | Changer | multi-passionate Leader

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. Some of my core skills include the following: Regulatory Strategy | Lean Quality Management | Quality & Regulatory as a Service | Project Management | Operations Management | Business Growth | Team Development & Leadership | Strategic Planning & Execution | Cross-functional Collaboration | Relationship Building If there are any further concerns or queries, please contact me on linkedIn or connect with me today to find out how I will make your mission my mission to help bring all your business objectives into focus. DISCLAIMER: All my posts are in my own name and on my own behalf and not related in any form to any of my companies or clients and may not reflect their opinion and are no indicator for any development in the future.