Robin Ziemianin Email & Phone Number

Lille, Fr

Ville De Paris, Île-De-France, France

Lille, France

Services offered- Internal or mock audits (of the system or on specific processes)- Assistance on answers and follow-up of nonconformities issued by a notified body- Specific consultancy mission depending on the needs

Loos, Hauts-De-France, France

Mains achievements :- Obtention of ISO 13485:2016 certification with a new notify body (BSI) and QMS conformity assessment regarding MDR 2017/745 requirements- Participation in obtaining the CE marking certification under MDR 2017/745- Significant reduction in the number of nonconformity raised during third party audits (-80%) and of their processing time- Total redo of some major processes and of their associated interactions and KPIs- Implementation of a new reinforced internal audit processTasks :- Management of the QMS, its processes and activities following ISO 13485, MDR 2017/745 and MDSAP requirements (21 CFR Part 820, RDC ANVISA 665/2022, MHLW MO 169, TG(MD)R Sch3, Health Canada)- Project tracking and coordination of Quality and Regulatory Affairs department- Primary contact during third party audits and answers to raised deviations- Participation of interservice activities (risk management, design reviews, HR, etc.)- Collection, analysis and follow-up of nonconformities and complaints- Selection, assessment, and audit of suppliers- Research, analysis and reporting of quality management measurement criteria (indicators, trend report, etc.)- Planification and realization of management reviews- Codification, control and dissemination of quality documents and records- Corrective and preventive actions follow-up- Control of product release and traceability

Loos, Hauts-De-France, France

Establishment and update of regulatory files (CE mark and FDA)Planification and realization of the management reviewParticipation in the implementation of MDR 2017/745 and MDSAP (Medical Device Single Audit Program)

Loos, Hauts-De-France, France

Formalization of regulatory requirements in the QMS (distribution, training)Data management using VBA and Power BI, and implementation of dashboards

Vietnam

Internship subject : "Screening molecular markers to differenciate phytopathogenic fungi"Conferences and international meetings

Master'S Degree - Medical Devices And Biomaterials

Study of technical, regulatory, and R&D aspects of medical devices and biomaterials : - Design and development - Preclinical and clinical.

Master'S Degree (1St Year) - Pharmaceutical And Health Product Sciences

Acquisition of technical, clinical and regulatory skills relating to health products : - Regulations in pharmaceutical sciences.

Bachelor'S Degree - Cellular Molecular Biology And Physiology

Acquisition of fundamental principles and techniques of post-genomic biology seeking to link gene expression and physiological functions

Two-Year University Degree - Bio-Engineering

Specialisation in agri-food and biological industries