Head of Regulatory

Posted 26 July 2023
Job type Permanent
Contact NameShola Sonagara

Job description

Do you want to work for a forward-thinking & purpose-driven medical technology business based in Central London?

They are looking for a Head of Regulatory to handle FDA approval, CE marking and UKCA marking of their products.

This role will offer you
  • The chance to perform work that will help the lives of patients and healthcare professionals
  • A flexible and progressive working environment
  • Personal contribution to shape the company’s unique culture
  • Market leading benefits
You will be responsible for
  • Leading the Quality & Regulatory team
  • Creating applications to the FDA and other notified bodies to approve IVD and digital health products across US and Europe
  • Ensuring the QMS is compliant with ISO 13485 and FDA 21 CFR 820
  • Responsible for product regulatory strategy and regulatory approvals.
You will bring the following
  • Experience with FDA submission and IVD approvals (essential)
  • Experience with UKCA and/or CE marking of IVDs (essential)
  • Extensive experience with IVDD, IVDR, ISO 13485:2016, FDA 21 CR 820 (essential)
  • Ability to work rapidly and to be adaptable
If this sparks your interest, please GET IN TOUCH by applying through this ad or emailing me at shola.sonagara@biotalent.com!