Elena Martinz
Safety Physician at MED-EL- Claim this Profile
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Bio
Credentials
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Der Sicherheitsbeauftragte für Medizinprodukte.
Nürnberg, TÜV Rheinland Akademie GmbH -
Presenting with strength and self-confidence –
Nürnberg Akademie für Absatzwirtschaft -
Writing in the Sciences
Stanford University Online Course -
Österreichische Ärztekammerdiplom für Akupunktur
Österreichische Gesellschaft für Kontrollierte Akupunktur und TCM
Experience
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MED-EL
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Austria
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Medical Equipment Manufacturing
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700 & Above Employee
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Safety Physician
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أبريل 2014 - - الحالي
Product performance monitoring, vigilance and post-market surveillance activities related to medical devices with focus on medical and clinical cases in accordance to the Austrian Medical Device Law, the European Medical Device Regulation as well as worldwide applicable statutory requirements and guidelines.• Investigating, evaluating and following up on clinical/medical incidents of note• Support and/or perform incident investigations on medical and surgical cases, including root cause identification and documentation of results.• Perform literature review to support post-market surveillance activities
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Medical Writer
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أبريل 2010 - مارس 2014
• Write Clinical Evaluation Plans and Reports for medical devices, including reviewing and revising existing clinical evaluation reports• Systematic searches of literature in appropriate databases • Documentation of literature searches by writing literature search plans and reports• Proactive cooperation with Regulatory Affairs, R&D and Risk Management Departments• Review and develop company SOPs
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Clinical Research Manager
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يناير 2009 - مارس 2010
• Project management of regulatory required post-market clinical surveillance studies from protocol development through to preparation of final reports and publications • Liaison with Research and Development, Risk Management and Regulatory Departments• Provided instruction and scientific support to clinical staff, including the Principal Investigator • Reviewed regulatory documents• Assisted in grant writing and preparation of manuscripts
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Medical Assistant
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سبتمبر 2005 - يوليو 2006
• Developed study protocols • Analyzed data and presented final results at international conferences • Evaluated and diagnosed children and adults for the EEG-division• Planned weekly therapy for children with epilepsy, neuromuscular and metabolic disorders • Established and maintained excellent relationships with patients, families and nurses thorough consistent demonstration of professionalism and ethics • Developed study protocols • Analyzed data and presented final results at international conferences • Evaluated and diagnosed children and adults for the EEG-division• Planned weekly therapy for children with epilepsy, neuromuscular and metabolic disorders • Established and maintained excellent relationships with patients, families and nurses thorough consistent demonstration of professionalism and ethics
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Staff Nurse
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مارس 2004 - سبتمبر 2005
• Provided individual therapy for children with cognitive and physical disabilities • Conducted assessment and assisted in writing treatment plans • Implemented and reviewed clinical service • Provided individual therapy for children with cognitive and physical disabilities • Conducted assessment and assisted in writing treatment plans • Implemented and reviewed clinical service
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Education
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1997 - 2003
Università degli Studi di Modena e Reggio Emilia
Doctor of Medicine - MD, Medicine -
1992 - 1997
Liceo Scientifico Statale “Wiligelmo”, Modena, Italy (scientific secondary school)
Community
