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- Tasks: Ensure compliance in quality assurance for medical devices and manage supplier processes.
- Company: Join an innovative medical device manufacturing company making a difference in healthcare.
- Benefits: Enjoy a home-based role with flexible working options and opportunities for professional growth.
- Why this job: Be part of a team that impacts patient safety and product quality in the medical field.
- Qualifications: Experience with ISO standards and regulatory affairs in medical devices is essential.
- Other info: This role offers a chance to develop training materials and engage in risk management.
The predicted salary is between 36000 - 60000 £ per year.
Quality Assurance and Regulatory Engineer – Homebased Opportunity: Do you have experience in quality assurance and regulatory affairs for medical devices? Do you have experience of working to ISO 13485, ISO 14971 and UK MDR, Regulation (EU) 2017/745, MDSAP, ISO 9001 standards? Want to work for an innovative medical device manufacturing company? If yes then this is the role for you. Your role as a Quality Assurance and Regulatory Engineer will involve: Supplier & Purchasing: * Reviewing the supplier onboarding, supplier revaluation and purchasing processes to ensure compliance with specific country regulations. * Creating new documents to support the supplier and purchasing processes. * Establishing controls for critical suppliers. * Creating supplier quality agreements. Labelling * Reviewing product and software labelling and conducting a gap analysis to ensure labels meet all regulatory and compliance standards. Risk Management * Supporting product risk management activities according to current procedures. * Reviewing all processes within the quality management system and document process risks in accordance with ISO 14971. Trend Analysis * Establishing a process to collect, analyse and report on quality data to identify trends and areas for improvement. Training * Creating training material on relevant regulations, standards, and guidance (e.g. UK MDR, Regulation (EU) 2017/745, MDSAP, ISO9001). Regulatory…
Quality Assurance & Regulatory Engineer employer: Click To Hired
Contact Detail:
Click To Hired Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance & Regulatory Engineer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485 and UK MDR. This will not only help you understand the role better but also allow you to speak confidently about your knowledge during any interviews.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who work in quality assurance and regulatory affairs. Attend relevant webinars or local meetups to build connections that could lead to referrals or insider information about the role.
✨Tip Number 3
Prepare to discuss your experience with supplier management and risk assessment in detail. Think of specific examples where you've successfully navigated compliance challenges, as these will demonstrate your practical knowledge and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and changes in medical device regulations. Subscribe to industry newsletters or follow relevant organisations on social media to ensure you can bring fresh insights to the table during discussions with us.
We think you need these skills to ace Quality Assurance & Regulatory Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality assurance and regulatory affairs, specifically mentioning your familiarity with ISO 13485, ISO 14971, and UK MDR. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about working in the medical device industry. Discuss your relevant experience and how it aligns with the responsibilities of the Quality Assurance & Regulatory Engineer position.
Showcase Relevant Achievements: Include specific examples of past projects or roles where you successfully implemented quality management systems or improved compliance processes. Quantify your achievements where possible to make a stronger impact.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in quality assurance roles.
How to prepare for a job interview at Click To Hired
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and UK MDR regulations. Be prepared to discuss how your experience aligns with these standards and provide examples of how you've applied them in previous roles.
✨Demonstrate Your Analytical Skills
Since trend analysis is a key part of the role, be ready to talk about how you've collected and analysed quality data in the past. Share specific instances where your analysis led to improvements or changes in processes.
✨Showcase Your Documentation Skills
Highlight your experience in creating documents for supplier quality agreements and labelling compliance. Bring examples of documentation you've worked on to demonstrate your attention to detail and understanding of regulatory requirements.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in quality assurance. Think of situations where you had to manage risks or ensure compliance, and be ready to explain your thought process and actions taken.
