Head of Medical - Stealth MedTech Startup

BCG Digital Ventures is an ever-growing global team of entrepreneurs, designers, engineers, product experts and investors. We invent, build and launch startups with the world’s most influential companies. The business ventures we create build strategic advantages for the most important global companies enabling them to own the next horizon of innovation.    

We are getting ready to launch and scale a stealth startup, ready to transform the medical remote monitoring space. We are building an AI-powered device-agnostic platform, supported by a robust protocol and algorithm. With funding already in place, this startup is well positioned to disrupt the multi-billion dollar US home monitoring industry, with a readiness to transform patient care through convenience, better patient outcomes and reduced costs to the overall HC system.    

We are looking for an exceptional Head of Medical to join as part of the founding team to launch and scale this disruptive startup.

As the Head of Medical, you will:

  • Provide overall direction through the strategic development and execution of a clinical development program
  • Collaborate with Engineering, Product, and Commercial teams to align development to needs of the business
  • Prepare, review and revise policies and procedures to meet development objectives
  • Define clinical trial strategy, overseeing design, setup, conduct, and analysis
  • Oversee the preparation of, and review, regulatory filings, including direct interactions with regulators
  • Review marketing material and comment on required disclosures
  • Perform and review testing of the compliance program
  • Interact with high priority provider customers
  • Prepare and present training to firm employees

Desired Expertise & Experience

  • 10-15 years of relevant experience
  • Clinical development experience in medical devices with a preference in remote monitoring/diagnostics
  • MD and/or oncology experience a plus
  • At least part time to begin with, transitioning to full time before end of 2018
  • Direct experience in assembly, submittal, negotiation and clearance of 510(k)
  • Direct experience in setting up and managing a QMS compliant with FDA and Notified Bodies
  • Experience in FDA audits as principle interface between company and FDA auditor
  • Strong analytical, problem-solving and organization skills
  • Able to manage multiple priorities with accuracy and efficiency while meeting deadlines
  • A visible, approachable individual who is a transparent, proactive and effective communicator
  • Certified ISO auditor is a plus
  • Direct experience in vital signs Class II devices is a plus
  • Experience in managing staff of quality engineers, manufacturing quality personnel and V&V engineers is a plus

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