Ulrike Bormann

Since 03/ 2022 Participation incl. certificate confirmations in FDA Conferences & Seminars in Medical Technology, Pharmacy & Materials Sciences: „Regulatory Education for Industry“ "Building Medical Device Supply Chain Resilience" „Quality Management Maturity“ „Regulatory Fitness in Rare Disease Clinical Trials“ „Generic Drugs Forum 2022“ „Considerations Transbronchoscopic Thermal Ablation Devices“ „[...] Experiences in Point of Care 3D Printing of Device & Implementing a Quality Management System“

Activities besides professional station: - Social engagement (ÖAV, NABU) - Proactive participation in training courses in Materials Science/ (Bio-) Medical Engineering & Sciences / Regulatory Affairs / QM - Open minded for new professional challenges & approriate demanding activities as auditor, QM & RA (senior) Manager based on scientific engineer of Biomedical Engineering (Master of Science (univ.)) & Materials Science (Bachelor of Science (univ.) - Advanced Materials)

- Maintenance/ adaptation of QMS acc. MDD/ MDR - Leading/ technical management of CAPA procedures - Management, conduct & follow-up of Internal Audits - Accompaniment, prepare & follow-up of 3rd Party Audit - Management & approval of suppliers/service providers - Management & monitoring of change management - Training management supporting HR - Conducting training in QM, RA & QA - QA/ control: sterilization batch release, assessment of EO sterilization validation documentation, managing cleanroom monitoring

- Manage & conduct regulatory strategy for Australia/ successful completion - Registration activities for EU e.g. Spain & Portugal - Draw up & maintenance of QM documentation acc. EN ISO 13485, MDD, MDR, TG(MD)R & 21 CFR Parts 803, 806, 807, 820 & 821 - Support & prepare external audit acc. MDSAP - Manage, maintain & prepare/adapt technical & approval documentation acc. regulations - Support R&D for & draw up/ review development activities documentation & change management - Conduct trainings in RA, QM, QA

Regulatory Affairs Projekte im Rahmen der Zulassungsstrategien für Endoskope, dazugehörige Konformitätsbewertungsverfahren nach Medical Device Regulation und Unterstützung von Entwicklungsprojekten

Auditorin und Gutachterin/ Fachexpertin für nichtaktive Medizinprodukte im Rahmen des Geltungsbereichs der Benannten Stelle ecm GmbH zur Überprüfung und Bewertung von QM-/QS-Systemen sowie von Produktentwicklungen und entsprechender QM- bzw. technischer Dokumentationen

Consultant for Synthes GmbH, Zuchwil/ SO, Switzerland, as Product Development Engineer for Technical File Remediation within the Medical Technologies departmen of Real Staffing Group payrolled by Edelway AG.

Working in interdisciplinary project teams & with international business partners in Medical technology industry Synthes GmbH, Johnson & Johnson Medical Companies (10/2015-02/2016): - Sustaining Engineering/ Production Development, R&D, for Power Tools of Surgical Instruments - Assessment, Support and Development of Design and material scientific topics of Sustaining Engineering & material related support to other departments documented in technical files & design control documentation

R&D Implant Development for Medical Engineering/ Cochlea Implants, Elektromedizinische Geräte GmbH: - Development and technical assessments of electronic CI-components in interdisciplinary projects - Organization and implementation of material characterization and alternative test methods - International supplier business & supplier qualification incl. technical assessments & specimen testing - Adapting and development of processes for corrosion protection of Nitinol and light metal components

R&D Engineer Internship - Central R&D/ Applied Research Materials, Robert Bosch GmbH to investigate Cordierite for Diesel particulate filter, supervised by Dr. C. Engel: „Untersuchung der mechanischen Eigenschaften von Cordierit-Wabenkörpern und deren Degradation“ (1,5)

Industry internship in quality management of iron foundry Rexroth Guss GmbH - Material characterization/ thermochemical analysis of iron cast in melting production & final controlling

Corrosion testing of magnesium alloys and light metals at Institut für Metallurgie: - Determination & preparing potentio-dynamic tests & cross cuts

Research topic „Lasersintern von biokeramischen Knochenersatzmaterialien“ at Institut für Nichtmetalle, Clausthal-Zellerfeld: - Determination, preparing, sintering & materials characterization of Hydroxile apatite as bone substitute

Voluntary Social Year, Internationaler Bund - Franken, Workplace: University hospital Erlangen, Neurology with Epilepsy centre

Biomedical & cryogenic Engineering, Bio- & medical materials, Medical devices, bio-process & Laser technologies, computer aided tomographic methods; Master Thesis: investigation, simulation & characterization of Bioglas coated Nd containg Mg alloys, Publication: DOI: 10.1002/adem.201180078

Material scientific, technical/ engineering, physical & chemical knowledge, nano, surface, coating, preparation & characterization technologies within all materials groups e.g. ceramics, glass, binders, polymers, semiconductors, metals; Thesis: „Optical investigations of Nitrogen in Zinc oxide“(1.5)

Working place of voluntary service/ patient care: University Hospital Erlangen, Neurology with Epilepsy centre

Vertieft mathematisch-naturwissenschaftliches Profil