Regulatory Affairs and Quality Assurance Assistant - Cambridge

Newton Colmore Consulting Ltd; Cambridge; On-site; GBP 60,000 - 80,000; Full time

Job description

Regulatory Affairs and Quality Assurance Assistant - Cambridge, Cambridge

Client: Newton Colmore Consulting Ltd

Location: Cambridge, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference:

29261556f9ee

Job Views:

6

Posted:

27.06.2025

Job Description:

We are seeking a Regulatory Affairs and Quality Assurance Assistant for a medical devices company based in Cambridge. The successful candidate will support the company's Quality Assurance and Regulatory Affairs Manager, providing advice on product creation and improvement, and ensuring compliance with standards such as FDA 510k, ISO 13485, and FDA 21 CFR Part 820.

Knowledge of design processes is advantageous but not essential. The role involves collaboration with R&D teams, especially in relation to regulatory submissions, although writing submissions is not the primary responsibility.

Applicants should have experience with medical devices regulations, particularly ISO 13485 and FDA 510k. QMS experience is highly desirable and should be highlighted on your CV.

Candidates should hold a 1st or 2:1 degree in engineering or sciences and have some experience in regulatory affairs or quality assurance. Experience within a medical devices R&D or design team is preferred.

The company offers career progression, a competitive salary, benefits, and share options. If you are passionate about medical devices and regulatory affairs, apply now to join this innovative team.

For more information, contact Andrew Welsh, Director of Medical Devices Recruitment at Newton Colmore Consulting, at [phone], or apply directly through our platform.

Note: If you are not a passport holder of the country where the vacancy is located, a work permit may be required. Please check our blog for more information.

All applications should be submitted via the 'Apply now' button. Do not share bank or payment details during the application process.

Created on 27/06/2025 by TN, United Kingdom