Head of QARA

Head of QARA focuses on lead the qara function, own regulatory approvals.

What the role involves

• Lead the QARA function, own regulatory approvals.
• Ensure quality and compliance are embedded across the organisation as it continues to grow.
• Lead the Quality & Regulatory Affairs function, with full accountability for delivery, performance and outcomes.
• 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 the QARA function, while leading and developing the team.

Candidate fit

• Proven experience leading Quality & Regulatory functions within the medical device industry.
• Proven experience within a growing or scaling MedTech start-up environment.
• Proven experience delivering FDA 510(k) and EU MDR approvals for medical devices.

Additional role context

• Cure Talent are delighted to be partnered with an innovative medical technology company transforming access to ear and hearing healthcare.
• 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.