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DIRECTOR, MEDICAL DEVICES & DIGITAL LIFE SCIENCES | UK

Participate as a team member in innovative and multidisciplinary digital projects in an international environment

Role overview:

  • 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.

Required

  • 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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