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- Tasks: Support the Quality Assurance and Regulatory Affairs Manager in medical device projects.
- Company: Join a growing medical devices company in Cambridge focused on innovation.
- Benefits: Enjoy career progression, excellent salary, benefits package, and share options.
- Why this job: Work on life-improving devices and gain hands-on experience in regulatory affairs.
- Qualifications: 1st or 2:1 degree in engineering or sciences; experience in regulatory affairs is a plus.
- Other info: Apply quickly to secure your chance in this competitive role!
The predicted salary is between 28800 - 48000 £ per year.
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 is 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.
Regulatory Affairs and Quality Assurance Assistant - Cambridge) employer: Newton Colmore Consulting
Contact Detail:
Newton Colmore Consulting 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 FDA 510k and ISO 13485 standards. Understanding these regulations will not only boost your confidence during interviews but also demonstrate your commitment to the role and the industry.
✨Tip Number 2
Network with professionals in the medical devices sector, especially those involved in regulatory affairs and quality assurance. Attend relevant industry events or join online forums to gain insights and potentially get referrals.
✨Tip Number 3
Prepare to discuss any past experiences you have with quality management systems (QMS) and how they relate to the role. Be ready to share specific examples of how you've contributed to compliance or quality improvement in previous positions.
✨Tip Number 4
Research the company’s recent projects and innovations in medical devices. Being knowledgeable about their work will help you stand out in interviews and show your genuine interest in contributing to their mission.
We think you need these skills to ace Regulatory Affairs and Quality Assurance Assistant - Cambridge)
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasise any experience you have in regulatory affairs or quality assurance, especially within the medical devices sector. If you've worked with ISO 13485 or FDA 510k standards, mention this prominently in your CV.
Tailor Your CV: Customise your CV to reflect the specific requirements of the Regulatory Affairs and Quality Assurance Assistant role. Include keywords from the job description, such as 'QMS experience' and 'medical devices knowledge', to catch the employer's attention.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your passion for the medical devices industry and your understanding of the regulatory landscape. Use this opportunity to explain how your background aligns with the company's needs and values.
Showcase Team Collaboration Skills: Since the role involves working closely with the R&D team, highlight any previous experiences where you collaborated with cross-functional teams. This will demonstrate your ability to communicate effectively and contribute to product development.
How to prepare for a job interview at Newton Colmore Consulting
✨Showcase Your Knowledge of Regulations
Make sure to highlight your understanding of ISO 13485 and FDA 510k during the interview. Be prepared to discuss how these regulations impact the development of medical devices and how you can contribute to ensuring compliance.
✨Demonstrate Team Collaboration Skills
Since this role involves working closely with the R&D team, be ready to share examples of how you've successfully collaborated in past projects. Emphasise your ability to communicate effectively and provide valuable insights to support product development.
✨Prepare for Technical Questions
Expect technical questions related to quality assurance processes and regulatory affairs. Brush up on your knowledge of QMS and be ready to explain how you've applied these principles in previous roles or projects.
✨Express Enthusiasm for the Role
Show genuine interest in the company and the impact of their medical devices. Discuss why you're passionate about working in regulatory affairs and quality assurance, and how you see yourself contributing to the company's mission.
