Greater Freiburg Area
Passionate about delivering exceptional service, I thrive on the diversity, humility, and rewards that come with being a dedicated service provider for our customer. Leadership & Management: Passion drives me to provide exceptional service, embracing the challenges and rewards that come with dedicated customer care. With over five years of experience as a managing director and a strong background in leadership for more than 10 years, I am well-versed in addressing complex customer requirements and ensuring quality. Fearless and Empathic Extrovert: As an extroverted, empathetic, and fearless professional, I am passionate about my job and unafraid to take risks. My enthusiasm and risk-taking nature drive me to achieve outstanding results. Connector and Collaborator: I excel in partnering and setting up cooperations, leveraging my ability to connect people and companies. My cross-functional thinking allows me to bridge gaps and foster collaboration. Hands-On Problem Solver: I'm driven by the challenge of finding solutions for our customers, no matter how difficult the problem. My stubborn determination and service-oriented mindset ensure that I never surrender in the face of obstacles. Cross-Functional Expertise in Pharma and Devices: My experience spans both the pharmaceutical and medical device industries, with a particular focus on combination products (device-drug and drug-device) and substance-based medical devices. This cross-functional expertise enables me to understand and navigate both worlds effectively. Quality Management Systems and Auditing Specialist: I am a process-oriented individual who takes great pride in the intricacies of Quality Management. I have extensive experience in building and auditing quality management systems within GxP and ISO environments. My expertise ensures that these systems are robust, compliant, and continuously improving. I am always eager to connect with others, tackle challenges, and enhance processes for superior service delivery. Let's connect and explore opportunities for collaboration in achieving exceptional outcomes together.
Manging Director at regenold GmbH
CE conformity assessment procedures for non-active medical devices of all risk classes. Specialised for drug-like medical and combination products incorporating, as an integral part, an ancillary medicinal substance. Establishment of Quality Management Systems according to EN ISO 13485 EN ISO 13485 auditing experience (Including supplier audits for clients e.g. raw material supplier, contract manufacturer and laboratories) Compilation of technical documentation for non active medical devices for all risk classes including maintenance in regard to regular updates of technical documentations in compliance to MDD/93/42/EEC Annex I Essential Requirements Risk Management according to EN ISO 14971 Support for annual audits at customer companies (according EN ISO 13485) Quality Management representative of the Integrated Management System of Medical DeviCE+ GmbH
NEXTEC medical GmbH acts as: - “legal” manufacturer according to Article 10 of MDR 2017/745 for products CE-marked and placed on the EU market -Authorized representative according to Article 11 of MDR 2017/745 for “legal” manufacturers outside EU -contract developer of medical device software including AI applications
Compilation of Module 3 and 2.3 (Quality) for drugs in DCP or MRP procedures as well as for international registrations Strategic support within final registration procedure in regard to authority communication Part of the Integrated Management System Team (IMS) of Dr. Regenold GmbH
- Product Manager for development of heart attack rapid tests (Point-of-Care-Tests) - Quality Management according to EN ISO 13485