Head of QA/RA

Overview

We are seeking an experienced and strategic Head of QA/RA to lead and develop our clients Quality and Regulatory function within a growing medical device organisation. This is a critical leadership role responsible for ensuring compliance with global regulatory requirements, driving quality excellence, and supporting the business through product development and commercialisation.

The successful candidate will play a key role in shaping and maintaining a robust Quality Management System (QMS), ensuring alignment with ISO 13485 and EU MDR, while building and mentoring a high-performing QA/RA team.

Key Responsibilities

Quality & Compliance Leadership

• Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in line with ISO 13485 and applicable regulatory requirements.
• Ensure ongoing compliance with EU MDR (2017/745) and other global regulatory frameworks.
• Act as the primary Quality and Regulatory representative for internal and external stakeholders.

Regulatory Affairs

• Oversee regulatory strategy, submissions, and approvals for medical devices across key markets.
• Ensure timely and accurate regulatory filings and maintenance of technical documentation.
• Maintain awareness of evolving regulatory requirements and implement necessary changes.

Audit & Inspection Readiness

• Lead internal and external audits, including notified body and regulatory authority inspections.
• Maintain audit readiness at all times.
• Serve as Lead Auditor, conducting internal audits and overseeing audit programmes.

Team Leadership & Development

• Build, lead, and develop a high-performing QA/RA function.
• Recruit, mentor, and retain talent within the quality and regulatory team.
• Foster a strong quality culture across the business.

Cross-Functional Collaboration

• Partner with R&D, Manufacturing, and Commercial teams to ensure quality and regulatory considerations are embedded throughout the product lifecycle.
• Provide strategic input to senior leadership on quality and regulatory matters.

Requirements

Experience & Qualifications

• Proven experience in a senior QA/RA leadership role within the medical device industry.
• Strong working knowledge of:
• ISO 13485
• EU MDR (2017/745)
• Demonstrated experience building and managing a QMS.
• Track record of hiring and developing QA/RA teams.
• Certified Lead Auditor (ISO 13485 or equivalent) essential.
• Experience leading audits with notified bodies and regulatory authorities.