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- Tasks: Lead quality assurance and regulatory affairs in the medical device sector.
- Company: Innovative tech business focused on medical devices.
- Benefits: Competitive salary, career growth, and a chance to impact healthcare.
- Other info: Collaborative team environment with opportunities to work with senior leadership.
- Why this job: Be at the forefront of bringing life-saving products to market.
- Qualifications: Experience in quality assurance and regulatory environments, especially in medical devices.
The predicted salary is between 60000 - 75000 £ per year.
My client, an innovative technology business within the medical device sector, are seeking a Quality Assurance Regulatory Affairs Manager to join their team. Working closely with senior leadership, R&D and operations, you will play a pivotal role in bringing products to market efficiently and compliantly.
Key responsibilities will include but are not limited to:
- Leading and developing the company’s Quality Management System
- Managing change control activities across products, processes and documentation
- Overseeing product and process validation activities in collaboration with technical teams
- Ensuring effective quality control processes across materials and finished products
- Driving compliance across risk management, CAPA and audit activities
- Supporting regulatory submissions and maintaining compliance across EU and US markets
- Acting as a key contact for regulatory bodies and external stakeholders
- Managing post-market activities, including complaints and ongoing product compliance
The successful candidate will have:
- Strong experience within Quality Assurance / Regulatory environments
- Background within medical devices, diagnostics or a regulated manufacturing setting
- Solid understanding of ISO12485 and 510K FDA submissions
- Experience working cross-functionally with technical and operational teams
Quality Assurance and Regulatory Affairs Manager employer: Eclectic Recruitment
Contact Detail:
Eclectic Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance and Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device sector on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Quality Assurance and Regulatory Affairs Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO12485 and 510K FDA submissions. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise when it comes to compliance and quality management.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills in Quality Assurance and Regulatory Affairs. We’ve got plenty of opportunities waiting for you!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show your genuine interest in the role and the company.
We think you need these skills to ace Quality Assurance and Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance and Regulatory Affairs Manager role. Highlight your experience in quality management systems and regulatory compliance, especially within the medical device sector. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how your skills can help us bring innovative products to market. Be sure to mention any specific experiences that relate to the key responsibilities outlined in the job description.
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just listing duties. Use metrics where possible to demonstrate your impact, like improvements in compliance rates or successful audits. We love to see how you've made a difference in previous roles!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy to do!
How to prepare for a job interview at Eclectic Recruitment
✨Know Your Regulations
Make sure you brush up on ISO 13485 and 510(k) FDA submissions before the interview. Being able to discuss these regulations confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Cross-Functional Experience
Prepare examples of how you've worked with R&D and operations in previous roles. Highlighting your ability to collaborate across departments will demonstrate that you're a team player who can drive quality assurance initiatives successfully.
✨Be Ready for Scenario Questions
Expect questions about managing change control activities or handling post-market compliance issues. Think of specific situations where you’ve tackled challenges in these areas, as this will illustrate your problem-solving skills and practical experience.
✨Engage with Regulatory Bodies
Discuss any experiences you have had interacting with regulatory bodies or external stakeholders. Showing that you can effectively communicate and manage relationships with these entities will be crucial for the role.