Regulatory & QA Associate, Medical Devices – Cambridge

Newton Colmore Consulting Ltd; United Kingdom; On-site; GBP 35,000 - 50,000; Full time

Benefits offered by this job

Excellent salary

Benefits package

Career progression

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Job summary

A medical devices company in Cambridge seeks a Regulatory Affairs and Quality Assurance Assistant to support the Quality Assurance and Regulatory Affairs Manager. The role requires knowledge of ISO 13485 and FDA 510k, and involvement in R&D efforts. Ideal candidates will hold a relevant degree and have experience in regulatory affairs or quality assurance. The company offers excellent salary and career progression opportunities.

Qualifications

• Experience within regulatory affairs or quality assurance.
• Medical devices knowledge is essential, especially ISO 13485 and FDA 510k.
• QMS experience is highly desirable.

Responsibilities

• Support the Quality Assurance and Regulatory Affairs Manager.
• Advise on creation of new products and improvement of existing technologies.
• Ensure compliance with FDA and ISO standards.

Skills

Knowledge of ISO 13485

Understanding of FDA 510k

Quality Management System (QMS) experience

Knowledge of design processes

Education

1st or 2:1 degree in engineering or sciences

Job description

A medical devices company in Cambridge seeks a Regulatory Affairs and Quality Assurance Assistant to support the Quality Assurance and Regulatory Affairs Manager. The role requires knowledge of ISO 13485 and FDA 510k, and involvement in R&D efforts. Ideal candidates will hold a relevant degree and have experience in regulatory affairs or quality assurance. The company offers excellent salary and career progression opportunities.