Mathilde Vaczlavik

Support companies in the design and implementation of Quality Management Systems Define regulatory strategies tailored to their regulatory status (MDR, IVDR, GxP, CSP) EU & US market Support certification process - manage regulatory authorities questions & answers

SENIOR CONSULTANT at Core Health Partners (2024-09 – Present)

• Support companies in the design and implementation of Quality Management Systems
• Define regulatory strategies tailored to their regulatory status (MDR, IVDR, GxP, CSP) EU & US market
• Support certification process - manage regulatory authorities questions & answers
• Technical file and TMF due diligence & compliance assessment - remediation action plan
• Conduct of site initiation visit, monitoring visits and follow-up activities
• Review of source data, eCRF completion, queries and protocol deviations
• Writing and oversight of clinical investigation documentation and study processes
• Management of regulatory submissions and substantial modifications
• Cross functional clinical oversight involving investigators, clinical sites and independent committees, including safety governance, study compliance and resolution of operational and regulatory issues
• Lead an early-stage MedTech project focused on in the field of infertility
• Conduct market analysis, user interviews and competitor benchmarking to assess clinical need and positioning
• Apply a TRL methodology for product development: TRL Phase 1 & 2
• Perform global literature review on technical & clinical aspects using scientific methodology to reduce bias

QUALITY & REGULATORY AFFAIRS DIRECTOR at Hygitech (2021-09 – 2024-09)

Medical Device Manufacturer

• PRRC - Manage team activities and ensure regular reporting to the General Manager
• Manage regulatory transition activities for medical devices in the context of CE certificate suspension
• Ensure compliance of ISO 13485 Quality Management System and monitor operational activities, including PMS
• Writing of Biological Evaluation Report (BER)
• Validate technical files - establish and maintain EU declarations of conformity

QUALITY & REGULATORY RESPONSIBLE at Stimuli Technology (2019-09 – 2021-09)

MD Manufacturer | Startup Studio TechnoFounders

• Person Responsible for Ensuring Compliance with the Regulations (PRRC)
• Support conception, design transfer and manufacturing in compliance with regulatory requirements including V&V activities
• Obtain CE marking according to new UE regulation 2017/745 for a Class IIa medical device incorporating software
• Implement the quality management system using a risk management approach
• Develop the reimbursement strategy to support the marketing business model
• Writing Clinical Evaluation Report (CER) - Establish a clinical study PMCF RIPH3
• Manage relations with Competent Authorities and Notified Bodies
• Oversee supplier qualification and monitoring using risk-based auditing methodologies
• Lead and conduct supplier/manufacturing audits across Europe and Asia
• Manage complex strategic and regulatory projects (e.g. Biobank closure, change of products regulatory status)
• Regulatory communication support with FDA
• Coordinate product withdrawals, including evaluation of safety risks, implementation of corrective actions and stakeholder communication

PHARMACIST - QUALITY ASSURANCE at AIR LIQUIDE MEDICAL SYSTEMS (2017-02 – 2019-09)

Medical Devices Manufacturer

• Maintain the Quality Management System for Notified Body audits and Health Authorities Inspections
• Update the organization within 2017/745 Medical device regulation
• Manage and follow-up inspections by authorities: Brazil, China, South Korea
• Perform internal and external audits (qualified auditor)
• Manage validation lifecycle: risk assessment, validation planning, testing, periodic review
• Validate QMS computerized systems including production tools based on GAMP 5 methodology
• Support on going outsourcing activities related to the storage: storage, final customization, etc.

QUALITY AND REGULATORY MANAGER at AD SCIENTIAM (2015-2016 – 2015-2016)

Start-up | Apprenticeship | Development of digital solutions | iPEPS-ICM incubator

• Create a global risk management approach based on ISO 31000, ISO 14971 and ICH Q9 adapted to decision making in companies
• Implement a development processes for a MD software for multiple sclerosis in order to obtain CE mark
• Establish an ISO 13485 quality management system taking into account pharmaceutical companies regulatory requirements

Specialized Master in Global Risk Management – Ecole Nationale Supérieure des Arts et Métiers, Paris (2015 – 2016)

Doctor of Pharmacy – Faculty of Pharmacy Paris Sud 11 (92) (2009 – 2015)

Master 2 in Responsibility and quality management in health industries – Faculty of Pharmacy, University of Bordeaux (2014 – 2015)