Medical Director Anesthesia & Ventilation
Getinge AB / Administratörsjobb / Solna
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hela Sverige Getinge Group is in an exciting and intensive period of change and we are now recruiting a Medical Director Anesthesia & Ventilation to our Business Category Unit Acute Care Therapies (ACT) at the manufacturing site in Solna. The function is an interface between medical & clinical department, strategic department, R&D, marketing and executive functions. You will therefore interface with a wide variety of stakeholders inside and outside the organization. The position offers you a great opportunity to contribute to the function 's development and future success.
The Position
In this position you will be responsible for providing outstanding clinical competence for anesthesia and ventilation and its related applications.
Among your main responsibilities and tasks will be:
Strategic planning and development
Identification and analysis of new business opportunities for anesthesia/ventilation related solutions including support for market access
Authors and edits clinical documents and documents required for regulatory submissions to US and other global health authorities
Support R&D in during pre-clinical development and post-market device enhancements
Technical documentation
Lead authoring and responsibility for clinical evaluation reports and benefit-risk analyses according to FDA guidelines and MEDDEV 2.7./1 and related guidelines, regulations, processes
Contributes and support risk management for anesthesia and ventilation devices
Medical & Clinical research
Support for clinical trials regarding anesthesia/ventilation devices (e.g. protocol development, study report review)
Author/prepare "white papers"/clinical monographs/investigator brochures
Oversight of abstract, poster, manuscript, oral presentation development for scientific meetings and journals
Supports clinical marketing processes including KOL management
Other
Contributes to the development and standardization of templates and related standard operating processes
Contributes cross-functionally to the quality and regulatory groups for complaint and non-conformity assessment and clinical support
Contributes and supports education and training programs
The position is located at our manufacturing site in Solna. The role requires occasional international travel, approximately around 20-30 %. You will be reporting to the Chief Medical Officer in Rastatt, Germany.
We are looking for you to have the following experience:
Clinical expertise as Board-certified anesthetist and intensive care physician with at least 10 years of clinical experience
Ideally MD/PhD with 5+ years of experience in research and good track record of publications
Profound understanding of clinical guidelines and their application in clinical practice; ability to identify 'pain points' along a disease
Experienced in authoring Clinical Evaluation Reports in accordance with MEDDEV requirements
Clinical study experience; Good Clinical Practice and ISO 14155 familiarity
Successful interactions with key external experts, health care providers, hospital administrations
Ideally good knowledge of Maquet or equivalent anesthesia and ventilation devices
Good knowledge of MS Office including Word, PowerPoint and Excel
Excellent knowledge of databases for scientific literature and bibliographic software, e.g. EndNote
As a person you are a committed and driven team-player in a dispersed team around the globe. You have an outstanding ability to communicate explicitly and clearly with various stakeholders and possess excellent presentation skills with particular focus on key messages. To succeed in this position, you need to have a good sense of structure and outstanding organizational skills. Additionally, you need to have the willingness to travel and a genuine interest in distinct cultural environments.
Together we can make a difference
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope - just to name a few.
A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
Publiceringsdatum2017-04-20Så ansöker duSista dag att ansöka är 2017-05-21
FöretagGetinge AB
AdressGetinge AB
Box 8861
40272 Göteborg
KontorsadressRöntgenvägen 2
Jobbnummer 3448440
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