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- Tasks: Lead Quality & Regulatory Affairs for innovative medical devices and ensure compliance across markets.
- Company: Join a pioneering medical tech company transforming ear and hearing healthcare.
- Benefits: Competitive salary, career growth, and the chance to make a real impact in healthcare.
- Other info: Dynamic role with opportunities to build and scale a high-performing team.
- Why this job: Shape the future of medical technology and improve lives globally.
- Qualifications: Experience in leading QARA functions and navigating regulatory pathways in MedTech.
The predicted salary is between 80000 - 100000 £ per year.
Cure Talent are delighted to be partnered with an innovative medical technology company transforming access to ear and hearing healthcare. Operating at the intersection of medical devices and software, the business is scaling its global presence and is now looking to appoint a Head of QARA to take ownership of Quality & Regulatory strategy and delivery.
This is a senior, hands-on leadership role, responsible for defining and executing the pathway to market for a Class IIa device across the US, UK and Europe. You will lead the QARA function, own regulatory approvals, and ensure quality and compliance are embedded across the organisation as it continues to grow.
Key Responsibilities- Own and lead the Quality & Regulatory Affairs function, with full accountability for delivery, performance and outcomes.
- Define and deliver the regulatory pathway to achieve FDA clearance and CE marking for a Class IIa medical device across the US, UK and EU.
- Act as the accountable owner for regulatory submissions and authority interactions, leading engagement with FDA, notified bodies and other regulatory agencies.
- Build, structure and scale the QARA function, while leading and developing the team.
- Maintain and improve the Quality Management System in line with ISO 13485, FDA 21 CFR Part 820, EU MDR and EN 62304.
- Drive CAPA, non-conformances, change control and audit activity, ensuring effective implementation and closure.
- Oversee Technical Documentation and Design History Files to support global submissions.
- Ensure compliance of SaMD, embedding software lifecycle requirements across product development and the QMS.
- Lead audits and inspections, managing interactions and responses.
- Proven experience leading Quality & Regulatory functions within the medical device industry.
- Proven experience within a growing or scaling MedTech start-up environment.
- Proven experience delivering FDA 510(k) and EU MDR approvals for medical devices.
- Experience bringing medical devices to market, with ownership of regulatory pathways and outcomes.
- Strong knowledge of ISO 13485, IEC 60601 and IEC 62304, with experience across audits, technical documentation and design controls.
Head of QARA in Southall employer: CURE TALENT LIMITED
Contact Detail:
CURE TALENT LIMITED Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of QARA in Southall
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Head of QARA role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and EU regulations. We want you to be the go-to expert in the room, so practice articulating your experience with regulatory pathways and quality management systems.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've built and scaled teams in previous roles. We’re looking for someone who can inspire and develop others in the QARA function.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. We’re excited to see how you can contribute to transforming ear and hearing healthcare!
We think you need these skills to ace Head of QARA in Southall
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Head of QARA role. Highlight your experience in leading Quality & Regulatory functions, especially in the medical device industry. We want to see how your skills align with the job description!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that demonstrate your ability to define and execute regulatory pathways and lead teams effectively.
Showcase Relevant Achievements: Don’t just list your responsibilities; showcase your achievements! If you've successfully delivered FDA 510(k) or EU MDR approvals, let us know. We love to see quantifiable results that highlight your impact in previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
How to prepare for a job interview at CURE TALENT LIMITED
✨Know Your Regulations Inside Out
Make sure you brush up on the specific regulations related to Class IIa medical devices, especially FDA 510(k) and EU MDR. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led a QARA function in previous roles. Highlight your experience in building and developing teams, as well as how you've driven compliance and quality improvements.
✨Demonstrate Your Problem-Solving Abilities
Think of specific challenges you've faced in regulatory submissions or quality management and how you overcame them. This will illustrate your hands-on approach and ability to navigate complex situations.
✨Engage with the Company’s Vision
Research the company’s mission and recent developments in ear and hearing healthcare. Showing genuine interest in their innovative approach will help you connect with the interviewers and demonstrate your enthusiasm for the role.