21 Oct
Important Business
London
You will be offering strategic advice as the VP Regulatory Consultant for an exciting and innovative clinical stage AI-focused Biotechnology company. The aim is to revolutionise precision medicine with a focus on immunology by advancing their AI and drug discovery platform. They have successfully been through several funding rounds and will be raising more money come next year, so this role will be very important in that success.
About this role:
This is a unique interim opportunity where you will be the first regulatory point of contact for the business, bringing with you a wealth of expertise advising early-stage software biotech companies on regulatory strategies.
You will be the first and last voice on all regulatory matters and provide clear strategic direction for senior leadership. They would like someone to offer strategic advice for laboratory requirements and different types of approaches.
- 510(k) Pathway
- De Novo Pathway
- Clinical Decision Support (CDS)
What you'll need to succeed:
- Over 20+ years of Regulatory Affairs expertise, recently specialising in working with early-stage SaMD biotech companies
- Experience with the 510(k) Pathway, De Novo Pathway, and CDS
- Understanding and experience in t
And someone with experience of understanding the landscape for the potential laboratory requirements for these types of approaches depending on implementation
▶️ SaMD VP Regulatory Affairs Consultant Contract
🖊️ Important Business
📍 London