Participate as team member in innovative and multidisciplinary digital projects in an international environment
Serve as in-house Digital expert for internal (i.e. knowledge management, technological intelligence, etc.) and external projects ((i.e. active participation in conferences, contribution to business development, etc.)
Participate to 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.;
Provide advice on operational and technical Digital subjects (i.e. software design & development, specification settings, software verification & validation, SW as MD qualification, risk analysis, etc.);
Provide support for the preparation of Agency meetings (primarily EU and 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.)
3/5 years proven professional software engineering experience with medical digital systems, medical algorithm and SW as MD development, etc.;
Experience with Project Management is a plus
Strong written and verbal communication, presentation, and facilitation skills;
Strong problem solving skills;
Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
Client- and business-oriented;
Proven ability to meet deadlines;
Ability to work across multiple projects and prioritize based on timelines for client deliverables;
Ability to juggle multiple priorities and adapt quickly to new situations and new project demands;
Good command of MS Office (Word, Excel, PowerPoint) is required.
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