Regulatory Affairs and Quality Assurance Assistant - Cambridge)

Newton Colmore Consulting; Cambridge; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player in the medical devices sector is seeking a Regulatory Affairs and Quality Assurance Assistant. This exciting role involves supporting the Quality Assurance and Regulatory Affairs Manager in ensuring compliance with FDA and ISO standards while collaborating closely with the R&D team. Ideal candidates will possess knowledge of medical devices and regulatory affairs, and a degree in engineering or sciences. With opportunities for career progression and a competitive benefits package, this position offers a chance to contribute to life-improving technologies. Don't miss out on this opportunity to join a growing company making a difference in healthcare.

Benefits

Career Progression

Excellent Salary

Benefits Package

Share Options

Qualifications

• Essential knowledge of medical devices, ISO 13485, and FDA 510k standards.
• Experience in regulatory affairs or quality assurance is important.

Responsibilities

• Support the Quality Assurance and Regulatory Affairs Manager.
• Provide advice on product creation and improvement within regulatory standards.

Skills

Medical Devices Knowledge

ISO 13485

FDA 510k

Quality Management Systems (QMS)

Regulatory Affairs

Education

1st or 2:1 Degree in Engineering or Sciences

Job description

Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge

Due to the growth of a medical devices company based in Cambridge, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company's Quality Assurance and Regulatory Affairs Manager. The team provides quality assurance and regulatory affairs advice 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 it's not essential. This team does not just fill out quality assurance and regulatory documents; they will be very involved with the R&D team, providing vital advice on the creation of medical devices, and ensuring the team operates within the FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards.

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. If you do have this knowledge, I would advise making it clear on your CV as this is highly desirable in this role.

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; 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 is looking to recruit quickly. So, if you are interested in this role, I suggest applying immediately or risk missing out.