Asja Moerkamp, Ph.D.

Experience

• 

  Elisabeth Otter-Knoll Stichting

  Jan 2004 - Jan 2011

  Care- and nutrition-assistant

  - Independently planned and carried out activities to promote the physical, social, emotional, and intellectual well-being of elderly in permanent residential care- Consulted healthcare professionals about the client's care plan- Assisted clients in their daily activities and reported/documented changes in the client's condition

• 

  Student Select

  Jan 2007 - Jan 2007

  Student Job
• 

  Amsterdam UMC

  Jan 2008 - Jan 2008

  Department of Medical Microbiology and Infection ControlTitle: ESX-5 dependent PE _PGRS localization and expression in M. marinum

  • Bachelor's Internship

    Jan 2007 - Jan 2008

  • Administrative Assistant

    Jan 2008 - Jan 2008
• 

  Friedrich Miescher Institute for Biomedical Research

  Feb 2009 - Jul 2009

  First Master's Research Project

  Title: The Proteasome and the balance between mitosis and meiosis in the C. elegansgerm line

• 

  Hubrecht Institute, Developmental Biology and Stem Cell Research

  Feb 2010 - Jan 2010

  Second Master's Research Project

  Title: Wnt signaling through intestinal stem cell-expressed Frizzled receptors

• 

  Leiden University Medical Center

  Jan 2011 - Jan 2017

  Ph.D. student

  Title: The building blocks for cardiac repair: Isolation and differentiation of progenitorcells from the human heart- Independently designed, planned, and conducted research projects- Analyzed and interpreted large sets of scientific data- Wrote and published scientific articles in peer-reviewed journals: 9 articles (5 first author), 2 cover images, 1 manuscript submitted, and 5 manuscripts in preparation- Attended conferences and gave oral presentations in an international environment- Independently managed several short- and long-term research projects in parallel- Initiated and maintained collaborations with different departments, institutes, and companies- Supervised 3 master students: project design, training, reviewing of progress, and final report- Taught practical courses for bachelor students- Reviewed Ph.D. thesis and internal/external manuscripts for scientific journals- Proactively maintained databases (overview of human cardiac stem cell isolations)- Assisted in grant writing Weniger anzeigen

• 

  AO Foundation

  Jul 2018 - Sept 2018

  Medical Writer Trainee

  - Wrote medical device clinical evaluation report, including systematic reviewing of the literature and writing of state-of-the-art section- Designed presentation for industrial partner- Provided editing and proofreading support

• 

  Smith+Nephew

  Jan 2019 - now

  Regulatory Affairs Specialist

  Preparation and maintenance of regulatory submissions in the EU according to the newMedical Devices Regulation 2017/745 (MDR) - Class I to Class III- Prepared technical documentation for MDR submission and CE conformity assessment- Oversaw technical documentation maintenance- Reviewed and prepared documents related to e.g. device description, general safety and performance requirements, product verification and validation- Wrote Instructions for Use and Patient Information Leaflet- Verified and approved product labeling, safety literature, and marketing material foraccuracy, consistency, and regulatory compliance- Answered, supported, and coordinated regulatory questionsProduct data management- Collected and reviewed data for EUDAMED- Proactively kept internal regulatory and product databases up to date- Conducted gap analysis for procedures and templates and updated them according to the MDR requirements and harmonized them with corporate S+N policies and proceduresMDR implementation and change management- Organized document translations and online publication- Conducted impact assessment of MDR changes on global product registrations- Provided documentation to update global registrations if required- Worked with Regulatory and Quality Management Software- Assisted with the preparation and the conduct of Notified Body audits Weniger anzeigen