My mission is to ensure high quality products for users. My competencies in which qualifies me to work with my mission:• Regulatory experience with medical devices and machines to product regulatory compliance assurance.• Quality management knowledge within the standards of: ISO 13485 and 9001 makes me capable to work with the PDCA circle by a process-oriented approach with the purpose of quality assurance.• Risk management work experience with ISO 14971 and 62304, to continuous minimization of device risks.• Health economical consciousness makes med capable of pointing on the solutions in which delivers the most health for money.• Marketing og business understanding. • Clinical quantitative and qualitative research and gathering of clinical data, processing and writing is the cornerstone of my health knowledge.2017 - 2019: MSc - Medical Market Access. 2014 - 2017: BSc - Medicine with Industrial Specialization.Experience: • CE marking of machines and medical devices.Directives and regulations: Medical Devices (MDR 2017/745), Machinary, ECOdesign, RoHS, EMC, Low Voltage Electrical Equipment, Measurement instruments.• Other regulatory documents: Cosmetic regulation (1223/2009) And the Danish regulations: udbudsloven, købeloven, aftaleloven og markedsføringsloven.• Product development in R&D • Regulatory documentation• Person Responsible of Regulatory Compliance (PRRC) for medical devices• Health economic analyzes: Cost-effectiveness, cost-utility, cost-of-illness and budget-impact.Personally I’m always happy, structured, well considerate, a woman of order, creative and passioned of all the tasks I get my hands on. I love to develope myself and to learn from other professional disciplines.Have a cup of coffee with my, add me or contact me on: Mail: Johansentrisja@gmail.comPhone: +45 53541052Search terms: medical devices – regulatory compliance – quality – risk management – health economics – patient safety – quality development – medical market access – economics – marketing – statistics – communication – medicine – health – quantitative research – qualitative research – cost efficiency – marketing