Global Head of Quality & Regulatory Affairs

Inspiration Healthcare; Croydon; On-site; GBP 90,000 - 120,000; Full time

Job summary

Inspiration Healthcare seeks a Head of Quality Assurance and Regulatory Affairs in the UK to lead the Quality Assurance and Regulatory Affairs function, ensuring MDR compliance and regulatory registration across key markets. The role drives a culture of quality and regulatory excellence, aligning staff with policy and process adherence.

The postholder will maintain QMS, lead regulatory activities, and keep pace with global regulatory changes, supporting project and development teams across the

Qualifications

• Five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Responsibilities

• Act as Management Representative.
• Liaise with the Authorised Person under the EU Medical Device Regulation.
• Document processes for QMS per MDSAP and ISO 13485.
• Report to CEO on effectiveness of QMS and improvements.
• Promote awareness of regulatory requirements and QMS requirements.
• Develop global regulatory strategies for product registrations and implement the regulatory project plan.

Skills

Regulatory affairs

Quality management

Leadership

Communication

Regulatory strategy

Cross-market experience

ISO 13485

Job description

Inspiration Healthcare seeks a Head of Quality Assurance and Regulatory Affairs in the UK to lead the Quality Assurance and Regulatory Affairs function, ensuring MDR compliance and regulatory registration across key markets. The role drives a culture of quality and regulatory excellence, aligning staff with policy and process adherence.

The postholder will maintain QMS, lead regulatory activities, and keep pace with global regulatory changes, supporting project and development teams across the