Lena Hagman

Experienced business leader within the Medical Device and Life Science Industry. High Business orientation and deep knowledge of company acquisitions and integrations, experience in leading R&D, Operations, Quality, Regulatory and Medical Affairs. Focus areas and strengthens are change management mainly within business processes and efficiency. Extensive knowledge in the European and US Food & Drug Administration (FDA) laws and regulations. Many years’ experience of quality and regulatory remediation programs and multi-site FDA Consent Decree. Ranked as number 7 in The Healthcare Technology Report, “The Top 25 Women Leaders in Medical Devices of 2021”. June 2015 – current Executive Vice President Quality Compliance, Regulatory & Medical Affairs, Getinge AB • Member of Getinge Executive team, reports to President & CEO • Leading a global team, appr. 500 employees • Develop and manage the Quality, Regulatory and Medical Compliance strategy and initiatives. • Monitoring the company remediation program • Move to less notified bodies and implement the new EU-MDR • Develop and implement global quality tools and processes Sept. 2018 – Jan. 2022 Executive Vice President & Managing Director Cardiopulmonary, Getinge (role in parallel with the EVP Quality compliance, Regulatory & Medical Affairs responsibilities) • Member of Getinge Executive team, report to President & CEO • Leading a global team, appr. 1400 employees • Profit & Loss responsibility • Extensive remediation program and production efficiency strategy • Implement lean and efficiency programs to increase production output and profitability • R&D product portfolio pipeline strategy and initiatives