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- Tasks: Support quality assurance and regulatory activities in a dynamic medical device company.
- Company: Join a growing company focused on innovative healthcare solutions across the UK and Europe.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make a real impact on patient outcomes while working with cutting-edge medical technologies.
- Qualifications: A relevant science-based degree and experience in the medical device field are essential.
- Other info: Proficiency in multiple languages is a plus; strong attention to detail is crucial.
The predicted salary is between 36000 - 60000 £ per year.
Your new company is a growing medical device company specialising in product development, commercialisation, manufacturing, sales and distribution. The product range includes IV therapy, diabetes care, surgical, anaesthesia, sexual health, cosmetics, etc. With a strong presence across the UK and Europe, they are committed to delivering high-quality, innovative healthcare solutions that improve patient outcomes.
Your new role involves supporting all quality assurance and regulatory affairs activities, ensuring the company's policies are implemented as part of normal processes across the company. You will be involved in:
- Liaising with stakeholders to ensure compliance with the company's policies and procedures.
- Supporting the company's Quality Management System (QMS).
- Ensuring compliance with UKCA, EU MDR, FDA.
- Writing, reviewing, and maintaining technical files and other relevant regulatory documentation (e.g. MDD, UKCA, MDR, IVDR, Procedure pack).
- Product development.
- Keeping up with relevant regulations or ISO standards updates.
- Ensuring that the business is working towards a smooth MDR implementation/transition process.
- Coordinating both internal and external audits.
- Ensuring compliance is always kept to the highest standard.
- Document control - updating quality procedure documents and product fact sheets to ensure accuracy.
What you'll need to succeed:
- Experience within the medical device field, all classes of medical devices.
- Good general knowledge of ISO13485 is preferable.
- Relevant science-based degree.
- Logical thinking and proactive approach to problem-solving.
- Good interpersonal skills.
- Excellent report writing skills with strong attention to detail.
- Good organisational and time management skills, with the ability to prioritise and handle a complex, varied workload.
- Office software: Microsoft, Adobe, etc.
- Multi-language skill is an extra.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
RA/QA Officer employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land RA/QA Officer
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in the medical device industry, especially ISO 13485 and EU MDR. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the medical device sector through LinkedIn or industry events. Engaging with others in the field can provide valuable insights and potentially lead to referrals, which can significantly boost your chances of landing the job.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your problem-solving skills and attention to detail. Being able to articulate how you've successfully managed compliance or quality assurance tasks will set you apart from other candidates.
✨Tip Number 4
Demonstrate your organisational skills by preparing a structured approach to how you would handle the responsibilities outlined in the job description. Showing that you have a clear plan for managing audits and documentation will impress potential employers.
We think you need these skills to ace RA/QA Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in the medical device field, particularly focusing on quality assurance and regulatory affairs. Emphasise your knowledge of ISO13485 and any specific projects you've worked on that relate to the job description.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Mention your proactive approach to problem-solving and how your interpersonal skills will help you liaise with stakeholders effectively.
Highlight Report Writing Skills: Since excellent report writing skills are crucial for this position, provide examples of reports or documentation you have previously written. This could include technical files or regulatory documentation that demonstrate your attention to detail.
Showcase Organisational Skills: In your application, illustrate your organisational and time management skills. You might want to mention specific instances where you successfully managed a complex workload or coordinated audits, as this is key for the role.
How to prepare for a job interview at Hays
✨Know Your Regulations
Familiarise yourself with the relevant regulations such as UKCA, EU MDR, and FDA guidelines. Being able to discuss these in detail will show your understanding of the industry and your commitment to compliance.
✨Demonstrate Your Experience
Be prepared to share specific examples from your past experience in the medical device field. Highlight your involvement in quality assurance and regulatory affairs, and how you contributed to maintaining compliance.
✨Showcase Your Attention to Detail
Since the role requires excellent report writing skills and a strong attention to detail, be ready to discuss how you ensure accuracy in documentation and quality procedures. You might even want to bring samples of your work.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities and logical thinking. Prepare scenarios where you had to navigate complex regulatory challenges or coordinate audits, and explain your approach and outcomes.
