Participate as a team member in innovative and multidisciplinary digital projects in an international environment
- Participate as a team member in innovative and multidisciplinary digital projects in an international environment.
- Serve as in-house Digital expert.
- Participate in the definition and implementation of Digital regulatory strategies for MD software development, digital product positioning & market claims selection, clinical evaluation and registration of innovative medical digital systems on international market places, etc.
- Write, review and assemble high-quality regulatory submissions and applications, such as CE mark Technical File/510(k)/DeNovo/PMA dossiers, ISO14155 Clinical Trial application/IDE packages, FDA Q-submission meeting applications, etc.
- Advise early-stage clients into their development strategy for QMS creation, Risk management plan creation, Clinical evidence creation, CE mark technical Files filling.
- Provide advice on operational and technical Digital subjects (i.e. software design & development, specification settings, software verification & validation, cybersecurity, risk analysis, etc.).
- Provide support for the preparation of Agency meetings (primarily EU and/or US).
- Monitor, prioritize and supervise projects’ strategy, timelines, and milestones and communicate them to the project team members.
- Ensure compliance with regulations (i.e. MDR 2017/745, 21CFRPart800*, etc.) and applicable guidelines (i.e. ISO62304/62366, ISO14971, ISO13485, etc.)
- Stay up to date with Digital regulatory trends and requirements (including for cybersecurity protection, data confidentiality, etc.)
- Contribution to business development.
- Contribution to knowledge management, technological intelligence.
- Successful consulting practice and professional networking
- 7 to 10 years experience in Regulatory or Market Access affairs, including 5 years experience at managing people in a consulting environment
- Experience in the management of large projects (such as MAAs)
- International experience
- Advanced degree such as MSc/Ph.D., Medical Doctor, PharmD…- or equivalent in biomedical disciplines.
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