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- Tasks: Lead QA/RA activities and ensure compliance with Medical Device regulations.
- Company: Join a dynamic start-up developing life-changing medical devices.
- Benefits: Enjoy a hybrid work model and competitive pay of up to £500 per day.
- Why this job: Make a real impact in a collaborative culture that values innovation and respect.
- Qualifications: Experience in QA/RA for medical devices, focusing on FDA and ISO compliance required.
- Other info: Quick one-stage interview process for immediate start.
The predicted salary is between 40000 - 60000 £ per year.
Contract Quality Assurance (QA) / Regulatory Affairs (RA) Consultant - Medical Devices
Location: Greater Manchester (Hybrid)
Contract: 6 months initially
Rate: Up to 500 per day (Outside IR35)
Start Date: ASAP
KO2's exclusive client is developing a life-changing Medical Device and is seeking an experienced QA/RA Consultant to support their Quality Assurance & Regulatory Affairs efforts.
The Role:
- Lead QA/RA activities, ensuring compliance with Medical Device regulations
- Take ownership of QMS implementation and Technical Files
- Focus on FDA 510(k), ISO 13485, and IEC 62304 compliance
- Work on a multi-disciplinary Medical Device project (Electronics, Software, Mechanical, Clinical)
- Join a dynamic start-up where you can make a real impact on Quality Assurance & Regulatory Affairs
- This is a hands-on role in a growing business with a fantastic culture- where collaboration, respect, and motivation drive innovation.
- A one stage interview can be quickly arranged.
QA / RA Consultant - Medical Devices - Contract employer: KO2 Embedded Recruitment Solutions Ltd
Contact Detail:
KO2 Embedded Recruitment Solutions Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA / RA Consultant - Medical Devices - Contract
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as FDA 510(k), ISO 13485, and IEC 62304. This knowledge will not only help you stand out but also demonstrate your commitment to compliance in the medical device sector.
✨Tip Number 2
Network with professionals in the QA/RA field, especially those who have experience in medical devices. Engaging with industry groups or forums can provide insights and connections that may lead to opportunities at companies like ours.
✨Tip Number 3
Prepare to discuss your hands-on experience with Quality Management Systems (QMS) and Technical Files during the interview. Be ready to share specific examples of how you've implemented these in past roles, as this will showcase your practical skills.
✨Tip Number 4
Research our company culture and values before the interview. Understanding what drives us at StudySmarter will help you align your answers with our mission and demonstrate that you're a great fit for our dynamic start-up environment.
We think you need these skills to ace QA / RA Consultant - Medical Devices - Contract
Some tips for your application 🫡
Understand the Role: Familiarise yourself with the specific requirements of the QA/RA Consultant position. Highlight your experience with FDA 510(k), ISO 13485, and IEC 62304 compliance in your application.
Tailor Your CV: Customise your CV to reflect relevant experience in Quality Assurance and Regulatory Affairs, particularly in the medical devices sector. Use keywords from the job description to make your application stand out.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the impact you can make in a start-up environment. Mention specific projects or achievements that demonstrate your expertise in QA/RA.
Highlight Soft Skills: In addition to technical skills, emphasise your ability to collaborate and communicate effectively within a multi-disciplinary team. This is crucial for a dynamic start-up culture.
How to prepare for a job interview at KO2 Embedded Recruitment Solutions Ltd
✨Know Your Regulations
Familiarise yourself with the key regulations relevant to the role, such as FDA 510(k), ISO 13485, and IEC 62304. Being able to discuss these in detail will show your expertise and readiness for the position.
✨Demonstrate Your Experience
Prepare specific examples from your past work that highlight your experience in Quality Assurance and Regulatory Affairs. Discuss how you've successfully implemented QMS or managed Technical Files in previous roles.
✨Show Your Collaborative Spirit
Since this role involves working on a multi-disciplinary project, be ready to talk about your experience collaborating with different teams. Highlight instances where your teamwork led to successful outcomes.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's culture, the team you'll be working with, and the specific challenges they face in QA/RA. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
