At a Glance
- Tasks: Lead Quality & Regulatory Affairs for innovative medical devices and ensure compliance across markets.
- Company: Dynamic MedTech company transforming ear and hearing healthcare.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Exciting opportunity to lead in a fast-growing start-up environment.
- Why this job: Join a pioneering team and shape the future of healthcare technology.
- Qualifications: Experience in Quality & Regulatory roles within the medical device industry.
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 Quality and Regulatory Affairs. Job in London LilyLifestyle Jobs employer: United Cerebral Palsy of Georgia
As an innovative medical technology company based in London, we pride ourselves on fostering a dynamic work environment that encourages creativity and collaboration. Our commitment to employee growth is evident through tailored development programmes and opportunities to lead impactful projects in the rapidly evolving field of ear and hearing healthcare. Join us to be part of a mission-driven team that values quality, compliance, and the transformative power of technology in improving lives.
Contact Details:
United Cerebral Palsy of Georgia Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality and Regulatory Affairs. Job in London LilyLifestyle Jobs
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. We can’t stress enough how important it is to make connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory challenges and be ready to discuss how your experience aligns with their needs. We want you to shine!
✨Tip Number 3
Showcase your leadership skills during interviews. Talk about how you've built and scaled teams in the past, especially in a MedTech environment. We love hearing about real-life examples!
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets noticed. We’re here to help you land that dream role in Quality and Regulatory Affairs.
We think you need these skills to ace Head of Quality and Regulatory Affairs. Job in London LilyLifestyle Jobs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Head of Quality and Regulatory Affairs role. Highlight your experience in leading QARA functions and any specific achievements in getting medical devices through regulatory pathways. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your experience fits with our innovative approach to ear and hearing healthcare. Be sure to mention any relevant experience with FDA and EU regulations.
Showcase Your Leadership Skills:As this is a senior role, we want to see evidence of your leadership capabilities. Share examples of how you've built and developed teams in previous roles, especially in fast-paced environments like MedTech start-ups. We love a good success story!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at United Cerebral Palsy of Georgia
✨Know Your Regulations
Make sure you brush up on the latest regulations and standards relevant to the role, like ISO 13485 and FDA 21 CFR Part 820. Being able to discuss these confidently will show that you're not just familiar with the requirements but also understand their implications in a practical setting.
✨Showcase Your Leadership Skills
As a Head of QARA, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've built and scaled teams in previous roles, and be ready to discuss your approach to developing talent within the Quality & Regulatory Affairs function.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about challenges you've faced in regulatory submissions or quality management and how you overcame them. This will help you illustrate your hands-on experience effectively.
✨Engage with the Company’s Vision
Research the company’s mission and recent developments in the medical technology space. Be prepared to discuss how your vision aligns with theirs and how you can contribute to their growth, especially in scaling their QARA function as they expand globally.
