At a Glance
- Tasks: Lead a focused team in ensuring quality and compliance for innovative medical devices.
- Company: Dynamic startup specialising in smart wearable technology.
- Benefits: Competitive salary of £65k, career growth, and a vibrant work culture.
- Other info: Fast-paced environment with opportunities to shape the future of healthcare technology.
- Why this job: Make a real impact in the medical device industry while leading a passionate team.
- Qualifications: 7+ years in Quality Assurance and Regulatory Affairs with a science or engineering degree.
The predicted salary is between 65000 - 65000 £ per year.
We have an exciting opportunity for a Head of Quality Assurance and Regulatory Affairs role in a Medical Equipment Manufacturing company. The company develops smart wearable technology. It is looking for an experienced individual who can understand and respond to client needs and difficulties while leading a small, focused team in a fast‑paced startup environment.
Requirements:
- A bachelor's degree in a science or engineering discipline is required.
- Extensive expertise in the biotech/medical device industry, with an emphasis on IVD.
- Working knowledge of medical equipment classified as Class I and Class II.
- Excellent ability to communicate.
- 7+ years of combined Quality Assurance, Regulatory, and Clinical Affairs expertise.
- Experience working in a mid‑sized or start‑up environment is required.
- Established solid working relationships with regulatory agencies.
- Capable of organising, prioritising, and executing to meet company objectives.
- Knowledge of ISO 13485, MDSAP, IVDR, and GxP regulations.
- Basic understanding of software nomenclature, testing, validation, and user requirements, as well as IQ/OQ/PQ.
- Considerable experience as the key point of contact for regulatory audits/inspections.
- Expert project management abilities are required to develop and implement RA/QA/CA plans.
- Cross‑functional leadership abilities.
Head of Quality Assurance and Regulatory Affairs (7 years experience, £65k, Medical Devices, London) employer: Mandarin Recruitment
Join a pioneering Medical Equipment Manufacturing company in London, where innovation meets purpose. As the Head of Quality Assurance and Regulatory Affairs, you will thrive in a dynamic startup culture that values collaboration and creativity, while enjoying competitive compensation and opportunities for professional growth. With a focus on smart wearable technology, this role offers the chance to make a significant impact in the biotech industry, supported by a dedicated team and a commitment to excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality Assurance and Regulatory Affairs (7 years experience, £65k, Medical Devices, London)
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Head of Quality Assurance and Regulatory Affairs role. You never know who might have the inside scoop on an opportunity or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485, MDSAP, and IVDR regulations. Be ready to discuss how your experience aligns with the fast-paced startup environment and how you can lead a team effectively. Show them you’re not just a fit, but the perfect fit!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation for the opportunity. It’s a great way to keep your name fresh in their minds and show your enthusiasm for the role.
✨Tip Number 4
Apply through our website! We’ve got loads of resources to help you stand out, and applying directly shows your commitment. Plus, it makes it easier for us to connect with you and get you into the right role faster.
We think you need these skills to ace Head of Quality Assurance and Regulatory Affairs (7 years experience, £65k, Medical Devices, London)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in Quality Assurance and Regulatory Affairs. We want to see how your 7+ years of expertise aligns with the requirements listed in the job description, especially your knowledge of ISO 13485 and IVD.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our fast-paced startup environment. Share specific examples of how you've led teams and tackled challenges in the biotech or medical device industry.
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your application reflects that. Use clear, concise language and structure your documents well. We want to see that you can communicate effectively, just like you would with regulatory agencies.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss any important updates. Plus, it shows us you're keen on joining our team!
How to prepare for a job interview at Mandarin Recruitment
✨Know Your Stuff
Make sure you brush up on your knowledge of ISO 13485, MDSAP, IVDR, and GxP regulations. Being able to discuss these in detail will show that you’re not just familiar with the requirements but can also apply them effectively in a fast-paced startup environment.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in previous roles. Highlight your experience in managing cross-functional teams and how you’ve navigated challenges in quality assurance and regulatory affairs. This will demonstrate your capability to lead in a small, focused team.
✨Communicate Clearly
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex concepts in a way that’s easy to understand, especially when discussing client needs and regulatory requirements.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think about past experiences where you had to respond to regulatory audits or inspections and be prepared to discuss how you handled those situations effectively.
