Quality & Regulatory leader at Breas Medical since Feb 2019. We aim to provide better breathing and quality of life to respiratory patients and ease the transition from hospital to home. MDSAP, ISO 13485, MDR CE-marking of class IIb devices and software, 510(k)s, regulatory market access in 40+ countries, global QMS processes together with a great team of very dedicated professionals. A highly focused leader with a strong grasp of how company-wide processes interact to deliver value, as well as regulatory and IT requirements. Key skills: Structuring complex assignments to reach clarity about goals and tasks. Helping teams see the big picture and understand next steps. Developing, inspiring, challenging and supporting team members to grow, move forward, take on new responsibilities, increase and share knowledge.Director of QA&RA at Ascom from Aug 2012 to Feb 2019. Workflow solutions for healthcare and other industries. Achievements: EU MDR gap assessment and transition, setup clinical data program, new 510(k)s and first MDD class IIb CE-marking. Established global QMS ISO 13485:2016 & QSR, 9001:2015, 14001:2015 & 80079. Successfully passed two FDA inspections and a Sweden medical products audit. Established end to end process from complaints to CAPA and supplier corrective action in JIRA. Regulatory approvals across Asia-pacific and placed new medical devices on the market, enabling sales growth. QA&RA due diligence on several M&A's.2010-2012: independent Management Consultant, delivering project management and advisory services to clients within medical device and healthcare within quality assurance, application of industrial IT and lean methods to improve operational performance and compliance. Projects included GxP-compliant electronic archiving, PDM, MES/LIMS.Background in project management, IT and management consulting.Specialties: Extensive program/project management skills based on Lean/Agile methods, visualisation and facilitation.Wide industrial IT knowledge including ERP, MES, LIMS, PLM/PDM, ecommerce.Well versed in quality management requirements from ISO 9001/13485 (Medical Device), FDA Part 820/Part 11, computerized systems validation, COBIT, ISO 27001. Worked with IT Governance, IT Outsourcing, Business Continuity Planning, and Risk Management.