Xenios AG - a company of the Fresenius Medical Care Group - is an innovative medical technology company focusing on heart and lung failure. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console. Xenios mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients that are awake, self-determined and mobile. Xenios AG has been part of Fresenius Medical Care, the world's leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group's portfolio in the area of holistic multi-organ support of FME.
Your Responsibilities:
- Serve as peer-to-peer medical-scientific and clinical contact person towards Health care providers (HCP), Key Opinion Leaders (KOL), Health Care Organizations (HCO), competent authorities and medical institutions in the health care system
- Provide subject matter expertise to internal stakeholders and project teams throughout the product lifecycle, in particular product development, risk management, usability, vigilance, strategic business development and post-market surveillance
- Provide subject matter expertise to the development and continuous updating of Clinical Evaluation Plans & Reports and PMCF activities in accordance with regulatory requirements (e.g. Medical Device Regulation, MEDDEV 2.7.1)
- Development and implementation of a (pre)clinical and economic evidence generation program to support global market access and reimbursement strategies and business development activities in the global market
- Establishment, maintenance and continuous updating of a network of medical-scientific experts (Key Opinion Leaders, KOL) and strategic involvement into Medical Affairs projects, e.g. by organizing, conducting and moderating medical-scientific events
- Plan, develop and implement medical-scientific and clinical communication concepts in accordance with the marketing plan, including
- Congress activities (e.g. symposia, workshops)
- Training and education of internal stakeholders and external HCP
- Identify needs, develop and implement medical-scientific and clinical education concepts in accordance with the marketing plan
- Training and education of internal employees
- Represent company’s interests in scientific congresses and medical events
Your Profile:
- Physician with academic degree
- 5+ years working experience as intensivist, anesthetist, cardiologist, cardiac surgeon or related field managing extracorporeal life support procedures
- Experience with clinical studies for regulatory and market access purposes
- Ideally working experience in medical device industry
- Proven experience in medical writing and medical-scientific publications
- Fluent in English language
- Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Ability to build credibility as medical and clinical subject matter expert
- Flexibility to travel (up to 30-50% of time) international
We offer you a position in a modern working environment with great personal responsibility, personal development prospects and the opportunity to be part of medical innovations. If you are looking for a future-oriented position in an international company, then we look forward to receiving your application via the career website of our parent company Fresenius Medical Care.