At a Glance
- Tasks: Support the Regulatory Affairs and Quality Assurance Manager in ensuring compliance for medical devices.
- Company: Dynamic medical devices company in Cambridge focused on innovation.
- Benefits: Competitive salary, career progression, benefits package, and share options.
- Other info: Fast-paced environment with opportunities for growth and involvement in R&D.
- Why this job: Join a team making a real difference with life-improving medical technologies.
- Qualifications: 1st or 2:1 degree in engineering or sciences; experience in regulatory affairs or quality assurance.
The predicted salary is between 30000 - 40000 £ 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.
Regulatory Affairs and Quality Assurance Assistant - Cambridge in London employer: Newton Colmore Consulting
Join a dynamic mechanical engineering services company that prioritises employee growth and development, offering clear progression pathways and a supportive work culture. With a focus on building long-term relationships and delivering exceptional service, you'll thrive in an environment that values your expertise and encourages innovation. Located centrally in Hampshire, this role provides the unique advantage of engaging with diverse industrial sectors across the South Coast, ensuring your contributions have a meaningful impact on the business's success.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs and Quality Assurance Assistant - Cambridge in London
✨Unlock Networking Opportunities
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Newton Colmore Consulting.
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We think you need these skills to ace Regulatory Affairs and Quality Assurance Assistant - Cambridge in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Newton Colmore Consulting!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Newton Colmore Consulting that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Newton Colmore Consulting!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Newton Colmore Consulting, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Newton Colmore Consulting
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Newton Colmore Consulting that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Newton Colmore Consulting’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
