A degreed professional with experience in the medical device industry with strong multi-functional regulatory, clinical, and quality assurance background. A fast track, highly motivated, team oriented engineer with strong technical background and with the following skills/abilities:
- To give consultancy about the product technical documentation necessary to comply with Directive 93/42/EEC and subsequent amendments;
- To create the documentation about medical devices given by the manufacturer to the user (labels and instructions for use);
- To provide support in regards to Risk Management process as well as writing, with shared responsibility, of the Plan Risk Management;
- To provide support with the risk analysis and the Risk Management Report, according to the standard EN ISO 14971;
- To make/prepare the Clinical Evaluation Based On The Literature, to extension of an existing clinical evaluation (if a device is already on the market) strictly developed to meet all of the requirements of the guide MEDDEV. 2.7.1 Rev.04;
- To create the Cosmetic Product Safety Report with the research of the scientific articles;
- To resolve the issues concerning the regulatory aspects of: classification of the specific type of the product, CE, marketing authorizations, import / export permits, verify the accuracy of labeling, compliance with the requirements of ‘U.S. FDA 510 (k) Medical Device Submissions Requirements, preparation of the technical documentation for medical devices, etc.;
- To know the requirements on Clinical Investigations laid out in annex VII of directive 90/385/EEC and in annex X of directive 93/42/EEC as amended by directive 2007/47/EC;
- To know the ISO 14155:2012 which describes the good clinical practice for design, conduct, recording and reporting of clinical investigations;
- To implement the quality certification systems according to the standards EN ISO 9001, EN ISO 13485 as well as the implementation of company management systems based on organization, resource development and management technique application (Analysis of service supply processes; Quality Manual writing; Procedure Writing; Audit; Specific Training;
- To provide support during the Management Review, for obtaining quality certifications and to maintain and improve the acquired system.
Demostrale ability to expand beyond the scope of assigned responsibilities to gain proficiency in new areas.