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
