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.