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- Tasks: Lead the Quality & Regulatory Affairs function for innovative medical devices.
- Company: Join a cutting-edge medical technology company transforming hearing healthcare.
- Benefits: Competitive salary, leadership opportunities, and a chance to make a real impact.
- Other info: Dynamic start-up environment with significant growth potential.
- Why this job: Shape the future of healthcare by ensuring quality and compliance in medical devices.
- 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.
Team Director in London employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Team Director in London
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We recommend practising common interview questions and tailoring your answers to highlight your experience in Quality & Regulatory Affairs.
✨Tip Number 3
Showcase your expertise! Bring along examples of your past work, especially any successful regulatory submissions or quality management systems you’ve implemented. We love seeing tangible proof of your skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who want to make a difference in the MedTech space.
We think you need these skills to ace Team Director in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Team Director. Highlight your experience in Quality & Regulatory Affairs, 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 achievements in leading QARA functions and navigating regulatory pathways. We love a good story that showcases your skills!
Showcase Relevant Experience: When filling out your application, be sure to showcase your relevant experience in delivering FDA 510(k) and EU MDR approvals. We’re looking for candidates who can demonstrate their hands-on leadership in a growing MedTech environment, so don’t hold back!
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’s super easy – just follow the prompts and let us know why you’d be a great addition to our team!
How to prepare for a job interview at Cure Talent
✨Know Your Stuff
Make sure you brush up on the latest regulations and standards in the medical device industry, especially 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 passionate about quality and regulatory affairs.
✨Showcase Your Leadership Skills
As a Team Director, you'll need to demonstrate your ability to lead and develop a team. Prepare examples of how you've successfully built and scaled teams in previous roles, and be ready to discuss your leadership style and how it aligns with the company's vision.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific challenges, like managing regulatory submissions or leading audits. Think of real-life scenarios where you’ve navigated complex regulatory pathways or resolved compliance issues, and be ready to share those stories.
✨Engage with the Interviewers
Don’t forget that interviews are a two-way street! Prepare thoughtful questions about the company’s growth plans, their approach to quality management, and how they envision the QARA function evolving. This shows your genuine interest and helps you assess if the role is the right fit for you.