Head of Quality & Regulatory - Medical Devices

Cure Talent; Thatcham; On-site; GBP 40,000 - 70,000; Full time

Job summary

An innovative surgical skills center is seeking a Quality Manager & Designated Individual to oversee compliance and quality systems in a state-of-the-art anatomy lab. This role offers a unique opportunity to take charge of regulatory oversight, ensuring the highest standards are maintained in surgical training and demonstration. The ideal candidate will have a strong background in Quality Management within HTA-regulated environments, coupled with a relevant degree in biological or medical sciences. Join a forward-thinking organization dedicated to excellence in education and development for the orthopaedics sector.

Qualifications

• Strong experience in HTA-regulated environments with compliance oversight.
• Proven background in Quality Management, ideally in medical or biosciences.

Responsibilities

• Maintain and develop the Quality Management System and compliance documentation.
• Lead HTA inspections and internal audits, ensuring staff training.

Skills

Quality Management

Regulatory Compliance

Risk Assessment

Internal Audits

Staff Training

Education

Degree in Biological Sciences

Degree in Medical Sciences

Tools

Quality Management System Software

Job description

Cure Talent is delighted to be supporting an advanced surgical skills centre delivering world-class education and development to the orthopaedics sector.
As part of their continued growth, they are seeking a Quality Manager & Designated Individual to take full responsibility for their Human Tissue Authority licence.

This is a rare opportunity to take ownership of compliance, lab quality systems, and regulatory oversight for a cutting-edge anatomy lab used for surgical training and demonstration.

Maintain and develop the Quality Management System, including SOPs, risk assessments, audits, and compliance documentation.
Lead on HTA inspections, internal audits, and staff training across all licensable activities.
Strong experience working within HTA-regulated environments, with a clear understanding of the regulations and inspection processes.
Proven Quality Management background, ideally within medical devices, biosciences, or healthcare.
A relevant qualification in biological or medical sciences, or equivalent practical experience.