Regulatory & Quality Lead - Medical Devices & ISO 13485

linkup; Bristol; On-site; GBP 45,000; Full time

Job summary

A leading supplier of medical devices in the UK is seeking a Regulatory Compliance Lead to oversee ISO management, regulatory documentation, and ensure compliance with healthcare standards. Candidates should have a degree in a relevant field and 5 years of experience in regulatory affairs or quality assurance. This role offers a salary of £45,000, flexible hours, profit share bonus, and additional benefits including free lunch, pension, and on-site parking.

Benefits

Free Lunch

Profit Share Bonus

23 days Holiday plus Bank Holidays

Pension

On site Parking

Qualifications

• 5 years' experience in regulatory affairs, quality assurance, or compliance.
• Strong understanding of international regulatory frameworks (e.g., ISO, MHRA, GDPR).
• Ability to manage multiple priorities and work independently.

Responsibilities

• Manage ISO 9001, ISO 14001 and ISO13485 systems.
• Compile and submit regulatory documentation.
• Conduct monthly inspections of non-conforming goods.

Skills

Regulatory affairs

Quality assurance

ISO compliance

Communication skills

Analytical skills

Education

Degree-level education in a relevant field

Tools

Document management systems

Microsoft Office

Job description

A leading supplier of medical devices in the UK is seeking a Regulatory Compliance Lead to oversee ISO management, regulatory documentation, and ensure compliance with healthcare standards. Candidates should have a degree in a relevant field and 5 years of experience in regulatory affairs or quality assurance. This role offers a salary of £45,000, flexible hours, profit share bonus, and additional benefits including free lunch, pension, and on-site parking.