Aurélie has been in the medical devices industry for over 10 years. Before joining NAMSA, Aurélie worked for 7 years as a consultant for several medical device manufacturers, primarily in hernia repair, wound care and orthopedics. She provided training and support on the development process, risk management, and technical and regulatory documentation for all classes of medical devices.

As a Principal Medical Writer at NAMSA since 2017, Aurélie coordinates, writes and reviews the content of documents. In particular, she has focused on supporting regulatory submissions with clinical evaluation plans and reports that conform to the European Medical Device Regulation (EU MDR). She is strongly involved in the continuous improvement of internal templates, work instructions and Standard Operating Procedures (SOPs), in partnership with other Medical Writers and Regulatory consultants.

Aurélie holds an Engineering degree and a Master of Science (MSc) in Material Sciences and Polymer Materials and Composites. She also has a PhD in Physiology and Biology of Circulation and Respiration. She has 8 years of experience working in research and development in industry and academia within European and international collaborations.

CORE COMPETENCIES 

• Over 10 years of professional experience in regulatory affairs relating to medical devices
• High familiarity with EU regulatory requirements
• Preparation and review of Clinical Evaluation Plans and Reports for CE certification, per MEDDEV 2.7/1 revision 4, in accordance with the European Medical Device Directive (MDD) 93/42/EEC (amended by the directive 2007/47/EC) and the European Medical Device Regulation EU MDR 2017/745
• Preparation of systematic literature reviews and analysis of data extracted from the literature for initial product development or regulatory submission
• Support for addressing non-conformities of clinical evaluations from Notified Bodies audits
• Development of templates, work instructions and SOPs for clinical evaluations
• Support on Risk Management per EN ISO 14971 via ad hoc advice or full preparation of Risk Management Files
• Technical documentation compilation and gap assessment
• Development and delivery of training materials related to CE-marking

RECENT PROJECTS

• Worked with several sponsors on transitioning clinical evaluations to meet MDR requirements
• Assisted sponsors with responses to Notified Bodies
• Assisted sponsors in the revision of the safety, performance and benefit claims

PUBLICATIONS

• Mazighi M, Tchétché D, Gouëffic Y, San Juan A, Louedec L, Hénin D, Michel J-B, Jacob M-P, Feldman LJ: Percutaneous transplantation of genetically-modified autologous fibroblasts in the rabbit femoral artery: A novel approach for cardiovascular gene therapy. J Vasc Surg 2006;44:1067-1075.
• Hlawaty H, San Juan A, Jacob M-P, Vranckx R, Letourneur D, Feldman LJ: Inhibition of MMP-2 gene expression with small interfering RNA in rabbit vascular smooth muscle cells. Am J Physiol Heart Circ Physiol 2007;293:H3593-601.
• San Juan A, Ducrocq G, Hlawaty H, Bataille I, Guénin E, Letourneur D, Feldman LJ: Tubular cationized pullulan hydrogels as local reservoirs for plasmid DNA. J Biomed Mater Res A 2007;83:819-827.
• San Juan A, Hlawaty H, Chaubet F, Letourneur D, Feldman LJ: Cationized pullulan 3D matrices as new materials for gene transfer. J Biomed Mater Res A 2007;82:354-362.
• San Juan A, Letourneur D, Izumrudov VA: Quaternized poly(4-vinylpyridine)s as model gene delivery polycations: structure-function study by modification of side chain hydrophobicity and degree of alkylation. Bioconjug Chem 2007;18:922-928.
• Collazos-Castro JE, Cruz AM, Carballo-Vila M, Lira-Cantú M, Abad L, Del Pino ÁP, Fraxedas J, San Juan A, Fonseca C, Pêgo AP: Neural cell growth on TiO2 anatase nanostructured surfaces. Thin Solid Films 2009;518:160-170.
• Hlawaty H, San Juan A, Jacob M-P, Vranckx R, Letourneur D, Feldman LJ: Local matrix metalloproteinase 2 gene knockdown in balloon-injured rabbit carotid arteries using nonviral-small interfering RNA transfection. J Gene Med 2009;11:92-99.
• San Juan A, Bala M, Hlawaty H, Portes P, Vranckx R, Feldman LJ, Letourneur D: Development of a functionalized polymer for stent coating in the arterial delivery of small interfering RNA. Biomacromolecules 2009;10:3074-3080.
• San Juan A, Montembault A, Gillet D, Say JP, Rouif S, Bouet T, Royaud I, David L: Degradation of chitosan-based materials after different sterilization treatments. IOP Conf. Ser.: Mater. Sci. Eng. 2012;31:12007.