VP of Regulatory Affairs - Digital Therapeutics

VP Regulatory AffairsUKReference: 3195
  • Highly visible - strategic role.
  • Flexible working.
  • Pivotal moment in the company’s history as they undertake a highly ambitious, yet achievable programme to apply their unique data-set to deliver accessible and best in class Mental Health treatments.

Zest Scientific has been instructed to identify a VP of Regulatory Affairs with global experience forged within Digital Health, MedTech or Digital Therapeutics (DTx). The VP of Regulatory Affairs will undertake a key strategic role overseeing both European and US submissions, providing strategic vision, expertise and leadership in the development of prescription Digital Therapeutics.

This is a highly impactful role where you will develop regulatory strategies for new Digital Therapeutics which use real-world data, applying Machine Learning, AI technology and Data Science to change patient pathways and deliver autonomous software products. The value proposition is particularly strong and the business is experiencing exponential revenue growth as they scale their commercial operations. 

The Candidate:

  • Accomplished Regulatory professional with extensive experience forged within the Medical Devices sector leading the compliance to the Medical Device Directive (MDD) in the EU, FDA, and other regulatory agencies.
  • Registering Software as a Medical Device (SaMD) would be particularly desirable; however, given the relative infancy of the DTx market we will also consider candidates with wider Medical Device experience proving there remains a strong software element to the technology.
  • Knowledge or experience in one of the following: ISO 13485; 21 CFR 820; 510K.
  • Comfortable working in a high growth / start up environment.
  • Strong results orientation and comfortable rolling your sleeves up to get things done.
  • Interest in Digital Health and the potential of Machine Learning to deliver improved clinical outcomes.
  • Demonstrates an interest in Mental Health provision and passionate about the opportunity to change the current treatment pathways.

The Role:

  • Undertake overall responsibility for the Regulatory Affairs function, providing strategic expertise as the business develops their product roadmap.
  • Coordinate all activities relating to regulatory compliance, including representation and delivering training across the business.
  • Provide technical expertise in relation to Clinical Studies required for regulatory approvals.
  • Provide input to development teams on design and process verification.
  • Provides an excellent platform for personal development working in an organization which is going through rapid scale up, positioning the technology for a global audience.

The Company:

  • Evidence based Digital Therapeutics company which is changing patient pathways and delivering improved clinical outcomes for patients suffering with some of the most common Mental Health conditions.
  • High growth business experiencing exponential growth.
  • Pivotal moment in the company’s history as they undertake a highly ambitious, yet achievable programme to apply their unique data-set to deliver accessible and best in class Mental Health treatments.

Remuneration:

Our client is committed to securing the services of the right candidate and is flexible with regards to the remuneration package and stock options available.  Zest Scientific is working to a strict deadline so in order to be considered for this opportunity please apply now and your application will be reviewed immediately.

Contact: Matthew Morland
Email: matthew.morland@zestbusinessgroup.com
Telephone: 0114 238 1724