Head of QARA

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Cure Talent are delighted to be partnered with an innovative medical technology company transforming access to ear and hearing healthcare. Operating at the intersection of medical devices and software, the business is scaling its global presence and is now looking to appoint a Head of QARA to take ownership of Quality & Regulatory strategy and delivery.
This is a senior, hands-on leadership role, responsible for defining and executing the pathway to market for a Class IIa device across the US, UK and Europe. You will lead the QARA function, own regulatory approvals, and ensure quality and compliance are embedded across the organisation as it continues to grow.
Key Responsibilities
Own and lead the Quality & Regulatory Affairs function, with full accountability for delivery, performance and outcomes. Define and deliver the regulatory pathway to achieve FDA clearance and CE marking for a Class IIa medical device across the US, UK and EU. Act as the accountable owner for regulatory submissions and authority interactions, leading engagement with FDA, notified bodies and other regulatory agencies. Build, structure and scale th...
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Location:
London
Salary:
£90,000
Job Type:
FullTime
Category:
Management & Consultancy

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