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 the QARA function, while leading and developing the team.
* Maintain and improve the Quality Management System in line with ISO 13485, FDA 21 CFR Part 820, EU MDR and EN 62304.
* Drive CAPA, non-conformances, change control and audit activity, ensuring effective implementation and closure.
* Oversee Technical Documentation and Design History Files to support global submissions.
* Ensure compliance of SaMD, embedding software lifecycle requirements across product development and the QMS.
* Lead audits and inspections, managing interactions and responses.
The Ideal Candidate Will Have
* 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.
* Experience bringing medical devices to market, with ownership of regulatory pathways and outcomes.
* Strong knowledge of ISO 13485, IEC 60601 and IEC 62304, with experience across audits, technical documentation and design controls
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