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- Tasks: Support the Quality Assurance and Regulatory Affairs Manager in ensuring compliance for medical devices.
- Company: Join a leading medical devices company in Cambridge, known for innovation and quality.
- Benefits: Enjoy career progression, competitive salary, benefits, and share options.
- Why this job: Be part of an innovative team making a real impact in healthcare.
- Qualifications: 1st or 2:1 degree in engineering or sciences; experience in regulatory affairs preferred.
- Other info: Work permit may be required for non-passport holders of the country.
The predicted salary is between 28800 - 48000 £ per year.
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 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 it\’s 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, 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 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. 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 has 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.
For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment, Science recruitment and Biotech recruitment specialists Newton Colmore Consulting, on +44 121 268 2240 or make an application, and one of our team at Newton Colmore Consulting will contact you.
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Regulatory Affairs and Quality Assurance Assistant - Cambridge employer: Newton Colmore Consulting Ltd
Contact Detail:
Newton Colmore Consulting Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs and Quality Assurance Assistant - Cambridge
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as FDA 510k and ISO 13485. Being able to discuss these standards confidently during an interview will show your genuine interest and understanding of the role.
✨Tip Number 2
Network with professionals in the medical devices field, especially those involved in regulatory affairs and quality assurance. Attend industry events or join relevant online forums to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Research the company’s recent projects and innovations in medical devices. This knowledge will not only help you tailor your conversation during interviews but also demonstrate your enthusiasm for their work and how you can contribute.
✨Tip Number 4
Prepare to discuss any relevant experience you have with Quality Management Systems (QMS). Highlighting your practical knowledge in this area can set you apart from other candidates and show that you are ready to hit the ground running.
We think you need these skills to ace Regulatory Affairs and Quality Assurance Assistant - Cambridge
Some tips for your application 🫡
Understand the Role: Read the job description carefully to understand the key responsibilities and requirements for the Regulatory Affairs and Quality Assurance Assistant position. Make sure you highlight relevant experience in your application.
Tailor Your CV: Customise your CV to emphasise your experience with medical devices regulations, particularly ISO 13485 and FDA 510k. Include any relevant QMS experience and ensure your educational qualifications are clearly stated.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical devices and regulatory affairs. Mention specific experiences that align with the role and express your enthusiasm for contributing to the company's success.
Follow Application Instructions: Ensure you apply through the 'Apply now' button on our platform. Double-check that all required documents are included and that your application is submitted before the deadline.
How to prepare for a job interview at Newton Colmore Consulting Ltd
✨Know Your Regulations
Familiarise yourself with key regulations such as FDA 510k and ISO 13485. Being able to discuss these standards confidently will show your understanding of the industry and impress the interviewers.
✨Highlight Relevant Experience
Make sure to emphasise any experience you have in regulatory affairs or quality assurance, especially within medical devices. Use specific examples from your past roles to demonstrate your skills and knowledge.
✨Showcase Team Collaboration Skills
Since the role involves working closely with R&D teams, be prepared to discuss how you've successfully collaborated with others in previous positions. Highlight any projects where teamwork was essential to achieving compliance or improving processes.
✨Prepare Questions
Have a few thoughtful questions ready to ask at the end of the interview. This shows your genuine interest in the role and the company, and it gives you a chance to learn more about their expectations and culture.
