At a Glance
- Tasks: Lead Quality & Regulatory Affairs for innovative medical devices and ensure compliance across markets.
- Company: Join a cutting-edge medical technology company transforming ear and hearing healthcare.
- Benefits: Competitive salary, career growth opportunities, and the chance to make a real impact.
- Other info: Dynamic start-up environment with a focus on scaling and global presence.
- Why this job: Be at the forefront of medical innovation and shape the future of healthcare.
- Qualifications: Experience in Quality & Regulatory roles within the medical device industry is essential.
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.
The Ideal Candidate Will Have
- 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. Job in London LilyLifestyle Jobs employer: United Cerebral Palsy of Georgia
As a pioneering medical technology company based in London, we offer an exceptional work environment that fosters innovation and collaboration. Our commitment to employee growth is evident through tailored development programmes and the opportunity to lead impactful projects in the rapidly evolving field of ear and hearing healthcare. Join us to be part of a dynamic team dedicated to transforming lives while enjoying a supportive culture that values quality, compliance, and professional advancement.
Contact Details:
United Cerebral Palsy of Georgia Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Head of QARA. Job in London LilyLifestyle Jobs
✨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 researching the company and its products. We want you to be able to discuss how your experience aligns with their mission in transforming ear and hearing healthcare. Show them you’re the perfect fit!
✨Tip Number 3
Practice your pitch! Be ready to explain your regulatory pathway successes and how you’ve led teams in the past. We suggest rehearsing with a friend or in front of a mirror to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Head of QARA. Job in London LilyLifestyle Jobs
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 background aligns with the key responsibilities mentioned in 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. Share specific examples of your experience with FDA approvals and CE marking, and how you've successfully navigated regulatory pathways in the past.
Showcase Your Leadership Skills:As this is a senior role, we want to see your leadership style. Include details about how you've built and developed teams in previous positions. Talk about your approach to maintaining compliance and quality management systems, as these are crucial for us.
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 out on any important updates. Plus, it shows you're keen on joining our innovative team!
How to prepare for a job interview at United Cerebral Palsy of Georgia
✨Know Your Regulations
Make sure you brush up on the key regulations like ISO 13485 and FDA 21 CFR Part 820. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply this knowledge practically in a leadership role.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in previous roles, especially in a QARA context. Highlight your experience in building and scaling functions, as well as how you’ve developed team members to achieve regulatory goals.
✨Demonstrate Your Problem-Solving Abilities
Be ready to discuss specific challenges you've faced in regulatory submissions or quality management. Use the STAR method (Situation, Task, Action, Result) to structure your answers and illustrate how you effectively resolved issues.
✨Engage with Their Vision
Research the company’s mission and recent developments in ear and hearing healthcare. Show genuine interest in their innovative approach and be prepared to discuss how your experience aligns with their goals for scaling globally.
