QARA Manager

Cure Talent is delighted to be working with an innovative MedTech company revolutionising ear and hearing healthcare! As part of their ongoing growth, we have a fantastic opportunity for a QARA Manager to lead and grow their Quality & Regulatory function.

We are seeking a dynamic and experienced Quality & Regulatory professional to head up the QARA team, oversee the company’s ISO 13485 certified QMS, and ensure regulatory compliance across UK, EU and global markets. This is a hands-on leadership role, offering the chance to shape the quality strategy in a fast-paced, software-driven medical device environment.

Key Responsibilities:

• Lead and manage the QARA team, ensuring clear direction, support and development.
• Oversee the QMS and ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and EN 62304.
• Govern quality system activities including CAPA, non-conformances, change controls, internal audits and training.
• Maintain Design History Files and Technical Documentation to support global market access.
• Provide regulatory input across the software and product development lifecycle.
• Prepare for and host external audits and inspections.
• Work cross-functionally to embed quality into operations, engineering and commercial teams.
• Stay up to date with evolving global regulations and guide internal teams accordingly.

The Ideal Candidate Will Have:

• Proven experience leading QA/RA teams in the Medical Device industry.
• Strong knowledge of ISO 13485, EU MDR, FDA QSR and EN 62304.
• Background in Software as a Medical Device (SaMD) is highly desirable.
• Experience managing audits, CAPA processes, and regulatory submissions.
• A collaborative leadership style with the ability to work at both strategic and operational levels.
• Excellent communication and organisational skills.

If you're looking for an exciting opportunity to lead quality and regulatory operations within a high-growth, purpose-driven MedTech company, get in touch today!