Global Medical Device Quality & Regulatory Engineer

Crux Product Design; Bristol; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Travel opportunities for global projects

Collaboration with multidisciplinary teams

Impactful work on healthcare technologies

Job summary

A consultancy in medical device development in Bristol is seeking a Quality & Regulatory Engineer passionate about ensuring device development aligns with latest guidelines. The role involves maintaining the ISO-certified QMS, supporting audits, and contributing to risk management. Ideal candidates will possess a good degree in a relevant discipline, extensive experience in quality assurance, and strong analytical skills. This position offers the opportunity to work with top pharmaceutical clients and influence the development of life-changing healthcare technologies.

Qualifications

• Strong relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Awareness of medical device related standards and guidelines (IEC 62366-1, ISO 14971, EU MDR, FDA guidance).
• Experience in technical documentation and regulatory submissions is desirable.

Responsibilities

• Embed quality throughout product development.
• Support validation of QMS systems.
• Support audits and change control.
• Contribute to risk management activities.
• Develop training materials to strengthen quality awareness.

Skills

Medical Device Quality Assurance

Regulatory Compliance

Analytical Skills

Problem-Solving Skills

Attention to Detail

Effective Communication

Education

Good degree in a relevant scientific/healthcare discipline

Job description

A consultancy in medical device development in Bristol is seeking a Quality & Regulatory Engineer passionate about ensuring device development aligns with latest guidelines. The role involves maintaining the ISO-certified QMS, supporting audits, and contributing to risk management. Ideal candidates will possess a good degree in a relevant discipline, extensive experience in quality assurance, and strong analytical skills. This position offers the opportunity to work with top pharmaceutical clients and influence the development of life-changing healthcare technologies.