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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 drives innovation.
- Qualifications: Experience in QA/RA, FDA 510(k), ISO 13485, and IEC 62304 compliance required.
- Other info: Quick one-stage interview process for immediate start.
The predicted salary is between 40000 - 60000 £ per year.
Medical Device Quality and Regulatory Consultant - Contract Opportunity
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.
Quality and Regulatory 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 Quality and Regulatory 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 during the interview but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience with QA/RA roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your discussions.
✨Tip Number 3
Prepare to discuss your hands-on experience with Quality Management Systems (QMS) and how you've successfully implemented them in previous roles. Be ready to share specific examples that highlight your problem-solving skills and ability to work in a multi-disciplinary team.
✨Tip Number 4
Research the company’s recent projects and developments in the medical device field. Showing that you are informed about their work and expressing genuine interest can set you apart from other candidates and demonstrate your enthusiasm for the role.
We think you need these skills to ace Quality and Regulatory Consultant - Medical Devices - Contract
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Quality and Regulatory Consultant position. Familiarise yourself with key terms like FDA 510(k), ISO 13485, and IEC 62304 to demonstrate your knowledge in your application.
Tailor Your CV: Highlight relevant experience in Quality Assurance and Regulatory Affairs specific to medical devices. Use keywords from the job description to ensure your CV aligns with what the company is looking for.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the medical device industry and your hands-on experience in QA/RA activities. Mention how you can contribute to their dynamic start-up culture and the specific projects they are working on.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in the QA/RA field.
How to prepare for a job interview at KO2 Embedded Recruitment Solutions Ltd
✨Understand the Regulations
Familiarise yourself with key regulations 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 role.
✨Showcase Your Experience
Prepare specific examples from your past work that demonstrate your experience in Quality Assurance and Regulatory Affairs. Highlight any successful projects or challenges you've overcome in similar roles.
✨Emphasise Collaboration Skills
Since this role involves working on a multi-disciplinary project, be ready to discuss how you have effectively collaborated with teams across different functions like electronics, software, and clinical areas.
✨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.
