Olaf H. Nitz

• Member of the Executive Management Team • 3 direct reports and management of intra disciplinary in-/external project teams • Maintaining the QMS in accordance with ISO 13485 & FDA 21 QSR 820 (MDR / ISO 13485:2016) • Change Management in accordance with 93/42 EEC • CAPA Management • Leading Supplier Audits • Elaboration the Regulatory Strategy for the US-Market (IDE/PMA) • Submission and execution of IDE Presub-meetings • Compilation and submission of technical files; Class IIb and III (cardiology)

includes the above as well • Integration of Software Development as core competency and the adoption of ISO 62304 • Risk management in accordance with ISO 14971 • Clinical Affairs support in: o Formulation and adoption of the clinical procedure to use “PiCSO” as an adjunct therapy for acute myocardial infarct patients o Preparation and conduction of clinical and experimental studies in the EU and CANADA (GLP) o SIV o User Trainings and Clinical Application

includes the above as well • Creation of Product labels • Technical writing of IFU’s and User Manuals • CE-marking of novel medical devices in accordance with 93/42 EEC device Class IIb and III (cardiology) • Successful certification of an entire new QM-System under ISO 13485 with in 14 months • Project Management in the development of a novel Medical Devices (PiCSO) for patients suffering Acute Myocardial Infarction (AMI, STEMI). Consisting of an 8F catheter and a control unit (PiCSO)

• Product Management for Software solutions for optimisation and traceability of production processes in industrial areas • Project Management of provided solutions for production processes and lines/machines in different branches (automotive, medical) • Leadership of project teams of 3 to 5 members • Acquisition (CH, EU) • Key Account Management (CH, EU)

- Market responsibility in Medical Technology and clusters in Medical Technology - Management of customer related outsourcing projects - Professional guidance of 5 employees - Management of a reorganisation project (Electronic Manufacturing), - Analysis/Development/implementation of operational and organisational structure

- Planning and coordination of PET-Bottle-Production including logistics - Dispatching of 3 and 4 shift operation - Supervision of 8 permanent employees - Member of the Q-Management team, responsible for inspection equipment (ISO 9000) - Project management of several customised projects and core project member for implementation of new ERP-System

- Development and optimisation of new processes and preparation for a future automation - Advisory service for Research and Development in manufacturing/assembly engineering - Professional guidance of 8 employees- Setup of the assembly line after the production transfer from the US - Short term assignment at OHAUS Corp., Florham Park NJ (USA), an affiliate of Mettler Toledo GmbH - Preparation of production- and process transfer to Switzerland, including a Clean room, FS-Class 10’000 (ISO 7)