Quality & Regulatory Engineer - Medical Devices

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

Job summary

A leading medical device consultancy in Bristol is seeking an experienced Quality & Regulatory Engineer to enhance ISO-certified quality management systems. The role focuses on integrating quality in product development, regulatory compliance, and risk management. Applicants should have a strong background in medical device quality assurance, demonstrate problem-solving skills, and possess effective communication abilities. Joining the consultancy offers a collaborative team environment with opportunities for mentorship and professional growth.

Benefits

Dynamic and supportive workplace

Collaboration in a multidisciplinary team

Opportunities for travel

Regular social events

Qualifications

• Relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Experience in technical documentation and regulatory submissions.
• Up-to-date with industry trends and best practices.

Responsibilities

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

Skills

Strong analytical and problem-solving skills

Effective communication skills

Attention to detail

Team collaboration

Knowledge of medical device standards

Proactive problem-solving

Mentoring skills

Education

Degree in a relevant scientific/healthcare-related discipline

Job description

A leading medical device consultancy in Bristol is seeking an experienced Quality & Regulatory Engineer to enhance ISO-certified quality management systems. The role focuses on integrating quality in product development, regulatory compliance, and risk management. Applicants should have a strong background in medical device quality assurance, demonstrate problem-solving skills, and possess effective communication abilities. Joining the consultancy offers a collaborative team environment with opportunities for mentorship and professional growth.