Head of Quality & Regulatory - Medical Devices

JR United Kingdom; Thatcham; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading company in the medical devices sector is seeking a Head of Quality & Regulatory to oversee compliance and quality systems in a cutting-edge anatomy lab. The role involves managing HTA inspections and ensuring regulatory oversight, making it vital for surgical training and demonstrations.

Qualifications

• Strong experience in HTA-regulated environments.
• Proven background in Quality Management within medical devices.

Responsibilities

• Maintain and develop the Quality Management System.
• Lead HTA inspections and internal audits.

Skills

Quality Management

Regulatory Compliance

Risk Assessment

Education

Qualification in Biological or Medical Sciences

Job description

Job Title:

Head of Quality & Regulatory - Medical Devices, Thatcham

Client:

Cure Talent

Location:

Thatcham, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

4

Posted:

12.05.2025

Expiry Date:

26.06.2025

Job Description:

Cure Talent is supporting an advanced surgical skills centre that provides world-class education and development in the orthopaedics sector. They are seeking a Quality Manager & Designated Individual to oversee their Human Tissue Authority (HTA) licence. This role involves taking full responsibility for compliance, lab quality systems, and regulatory oversight of a cutting-edge anatomy lab used for surgical training and demonstrations.

Responsibilities include:

1. Maintaining and developing the Quality Management System, including SOPs, risk assessments, audits, and compliance documentation.
2. Leading HTA inspections, internal audits, and staff training across all licensable activities.

Requirements:

• Strong experience in HTA-regulated environments, with a clear understanding of regulations and inspection processes.
• Proven background in Quality Management, ideally within medical devices, biosciences, or healthcare sectors.
• A relevant qualification in biological or medical sciences, or equivalent practical experience.