Position title
Regulatory Affairs and Quality Assurance Assistant – Medical Devices

Due to the growth of a medical devices company, based in South Birmingham, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the companies Quality Assurance and Regulatory Affairs Manager. The team provide quality assurance and regulatory affairs advise on the creation of new products and the improvement of existing technologies.

It would be highly advantageous if you have knowledge of design processes, but not essential. This team does not just fill out quality assurance and regulatory documents, this is a team where they will be very involved with the R&D team and providing vital advice on the creation of medical devices and making sure the team operate within the FDA 510k, ISO 13485 and FDA 21 CFR Part 820 standards.

It would be ideal if you have both quality assurance and regulatory affairs knowledge, however people have moved into this role from either regulatory affairs or quality assurance background, but with a general knowledge in the other side.

It is essential that you have medical devices knowledge especially ISO 13485 and FDA 510k knowledge.  Although writing submissions will not be a major part of your role you will relay information to the teams responsible for this, so ideally you will have done this in the past or at least assisted.

Ideally, you will have QMS experience, so if you do have this knowledge I would advise making it clear on your CV as this is highly desirable in this role.

The products this company have been developing are industry changing and will improve the lives of people around the world.

It is expected that you would hold a 1st or 2:1 degree within an engineering or sciences discipline along with some experience within regulatory affairs or quality assurance.  Although experience working within a medical devices R&D or design team is more important than education.

This is a growing company, due to this they offer career progression, excellent salary, benefits package, the chance to work on life improving devices and share options.

If you have regulatory affairs knowledge in the medical devices sector and are looking for a challenging role, then apply now.

I expect a lot of interest in this role and the company are looking to recruit quickly, so if you are interested in this role I suggest applying immediately or risk missing out on the role.

For more general information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment and Scientific recruitment specialists Newton Colmore, on 0121 268 2240 or make an application and one of our team at Newton Colmore Consulting will contact you. Please note we will not be able to discuss the role specifics until we have a copy of your CV.

Employment Type
Duration of employment
Medical Devices
Job Location
Birmingham, West Midlands
Date posted
1st June 2023
Valid through
30th September 2023
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Apply below or email directly: andrew.welsh@newtoncolmore.com

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