Mastère in Healthcare Law and Compliance Management
Programme at a glance
Mastère · 2 years · Paris College of Law and Justice
Start your applicationCompare tuition feesProgramme overview
Study legal responsibilities, data governance and compliance processes in healthcare. Medical-device and healthcare-organisation cases develop regulatory research, document review and risk analysis. Advanced study integrates regulatory strategy, technical evidence, post-market oversight, organisational governance and cross-functional compliance projects.
EDJ Paris — Paris College of Law and Justice. Duration: 2 years.
Mastère study builds on relevant undergraduate foundations, with advanced methods, complex cases and independent research or applied projects.
Study pathways
Medical-device regulation; health-data governance; healthcare organisational compliance. All pathways share a common core. Indicate your preferred pathway when applying; actual availability is confirmed before admission.
Learning outcomes
- Develop regulatory strategy skills in product pathways and responsibilities, explaining methods, evidence and limitations.
- Develop technical documentation skills in evidence, changes and review, explaining methods, evidence and limitations.
- Develop post-market management skills in monitoring, vigilance and action, explaining methods, evidence and limitations.
- Develop organisational governance skills in contracts, procurement and accountability, explaining methods, evidence and limitations.
- Develop health-data compliance skills in risk assessment and controls, explaining methods, evidence and limitations.
- Develop compliance project skills in gap analysis and corrective action, explaining methods, evidence and limitations.
Learning content and competency modules
| Module | Learning content | Assessment evidence |
|---|---|---|
| Regulatory strategy | Product pathways and responsibilities | Problem definition and reasoned analysis |
| Technical documentation | Evidence, changes and review | Reproducible case or model documentation |
| Post-market management | Monitoring, vigilance and action | Quality and traceability records |
| Organisational governance | Contracts, procurement and accountability | Comparison of options and testing evidence |
| Health-data compliance | Risk assessment and controls | Project plan and collaboration records |
| Compliance project | Gap analysis and corrective action | Integrated report and oral defence |
Study progression
- Year 1: deepen specialist methods, undertake literature or case research and define an independent project.
- Year 2: complete a research or applied project, evaluate methods and outcomes, and submit a final report and oral defence.
Projects and practice
Organise a medical-device compliance project with technical-document review, post-market monitoring and responsibility assignments.
Document the problem, working process, personal contribution, validation evidence and limitations. Individual contributions are assessed within team projects. Placements and external projects depend on actual arrangements.
Teaching and assessment
Legal reading, case seminars, document exercises and professional simulations develop reasoned analysis and practical judgement. Work remains within the applicable legal system and authorised professional responsibilities.
Assignments, case or laboratory work, staged projects and the final defence assess accuracy, methods, evidence quality, practical reliability and communication. Assessment weightings, reassessment and extension rules are published before teaching begins. Moodle may support resources, assignments, quizzes and feedback; specialist practical activities are assessed separately.
Entry requirements
Provide evidence of relevant undergraduate study or equivalent experience. Applicants should demonstrate strong reading, writing and analytical reasoning. Mastère applicants should explain relevant legal or professional foundations. Teaching-language and legal-system requirements are stated for each programme.
Submit education evidence, transcripts, a CV, a motivation statement and any requested project materials. Teaching language, language evidence and document-translation requirements are published for the intake. Website language does not determine teaching language.
Diploma
Complete the required modules, assessments and final project to receive an institution-issued diploma.
Career development
Medical regulatory affairs specialist; healthcare compliance project manager; medical-device compliance consultant. Employment depends on individual skills, experience and employer requirements. Regulated work requires the applicable qualifications and authorisations. Further study is assessed by the receiving institution.
French foundations and European perspectives
Healthcare and medical-device cases connect French responsibilities with relevant European Union regulatory frameworks, data protection and compliance evidence. Students distinguish product requirements from organisational responsibilities.
Tuition fees
| Study format | Per academic year | Full programme reference |
|---|---|---|
| Online | €4,900 | €9,800 |
| On campus | €7,900 | €15,800 |
Fees are charged per academic year. The full-programme reference assumes the same annual rate throughout the programme.
Apply to this programme
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EDJ Paris, a law school in Paris