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- Tasks: Lead Quality & Regulatory Affairs for innovative medical devices and ensure compliance across markets.
- Company: Join a pioneering medical technology company transforming ear and hearing healthcare.
- Benefits: Competitive salary, career growth opportunities, and a chance to make a real impact.
- Other info: Be part of a scaling MedTech start-up with a collaborative culture.
- Why this job: Shape the future of healthcare by driving regulatory success in a dynamic environment.
- Qualifications: Experience in Quality & Regulatory functions within the medical device industry is essential.
The predicted salary is between 80000 - 120000 £ 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.
Director (English/German Speaking) in London employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director (English/German Speaking) 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 Director (English/German Speaking) in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Director in Quality & Regulatory Affairs. Highlight your experience with FDA and EU regulatory pathways, as well as any leadership roles you've held in the medical device industry.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this position. Share specific examples of how you've successfully navigated regulatory approvals and led teams in a MedTech environment.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics where possible to demonstrate how you’ve improved processes or achieved compliance 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 out on any important updates!
How to prepare for a job interview at Cure Talent
✨Know Your Stuff
Make sure you brush up on the key regulations and standards 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 can also lead the QARA function effectively.
✨Showcase Your Leadership Skills
Prepare examples of how you've built and scaled teams in previous roles. This is a senior position, so demonstrating your ability to lead and develop a team will be crucial. Think about specific challenges you faced and how you overcame them.
✨Understand the Market
Research the company’s products and their current market position. Be ready to discuss how you would define and deliver the regulatory pathway for their Class IIa device. Showing that you understand their business model will set you apart from other candidates.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific regulatory challenges or compliance issues. Think through potential scenarios and how you would approach them, as this will demonstrate your problem-solving skills and strategic thinking.