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Regulatory Affairs Associate - South Birmingham

Birmingham   •  Negotiable  •  Permanent, Full time

Regulatory Affairs Associate - South Birmingham

Due to the growth of a medical devices company, based in South Birmingham, there is need for a new Regulatory Affairs Associate to work with and support the companies Quality Assurance and regulatory Affairs Manager. The team provide 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 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 strong regulatory affairs knowledge, however people have moved into this role from a quality assurance background in the past. 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.

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. 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.

You must have the right to work in the UK. Learn more

  • Agency: Newton Colmore Consulting
  • Reference: RAASB02
  • Posted: 26th May 2023
  • Expires: 23rd June 2023

Newton Colmore Consulting

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