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, career growth, and the chance to shape the future of healthcare.
- Other info: Fast-paced environment with opportunities for professional development and collaboration.
- 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 strong communication skills.
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 excellence in smart wearable technology. As an employer, we pride ourselves on fostering a collaborative and dynamic work culture that encourages professional growth and development, offering competitive salaries and benefits. With a focus on employee well-being and a commitment to regulatory excellence, this is an ideal environment for those looking to make a meaningful impact in the medical device industry.
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 devices field 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 openings 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. We want you to be able to showcase your expertise confidently, so practice articulating how your experience aligns with the needs of the company.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that excite you! Use our website to find roles that match your skills and interests. Tailor your approach to each company’s culture and values to stand out from the crowd.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
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 align 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. Whether it's through clear language in your CV or a well-structured cover letter, we want to see how you can convey complex information effectively.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. 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 cross-functional leadership and how you’ve managed to organise and prioritise tasks to meet company objectives. This will demonstrate your capability to lead 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 regulatory concepts in simple terms, as this will reflect your ability to respond to client needs and difficulties effectively.
✨Be Audit-Ready
Prepare to discuss your experience as the key point of contact for regulatory audits and inspections. Share specific instances where you successfully navigated these processes, as this will highlight your expertise and reassure the interviewers of your capabilities in managing compliance.
