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Head of Regulatory
- Posted 25 July 2023
- LocationLondon
- Job type Permanent
- Reference90681
- 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
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
- 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.
- 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
