At a Glance
- 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, dynamic work environment, and opportunities for professional growth.
- Other info: Be part of a scaling start-up with a focus on innovation and quality.
- Why this job: Make a real impact in healthcare by driving regulatory success for life-changing products.
- 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.
- 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 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 reflected in our hands-on leadership approach, providing opportunities for professional development while working on transformative healthcare solutions. Join us to be part of a dynamic team dedicated to making a meaningful impact in ear and hearing healthcare, all within a supportive and forward-thinking culture.
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 practising common questions and scenarios specific to Quality & Regulatory Affairs. We recommend doing mock interviews with friends or mentors to boost your confidence.
✨Tip Number 3
Showcase your expertise! Create a portfolio or presentation that highlights your achievements in QARA. This will help you stand out during interviews and demonstrate your hands-on experience.
✨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 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 related to FDA and EU approvals. 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 transforming access to ear and hearing healthcare. Share specific examples of how you've successfully navigated regulatory pathways in the past, as this will resonate with us.
Showcase Your Leadership Skills:As a senior role, we’re looking for someone who can lead and develop a team. In your application, mention any leadership experiences you’ve had, especially in scaling QARA functions. We want to know how you can help us grow!
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 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 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 them, but that you can lead the QARA function effectively.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in previous roles, especially in a MedTech start-up environment. Highlight your experience in building and scaling functions, as this is crucial for the Head of QARA position.
✨Demonstrate Problem-Solving Abilities
Be ready to discuss specific challenges you've faced in regulatory submissions or quality management systems. Use the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your problem-solving skills.
✨Engage with Questions
Prepare insightful questions about the company's current projects and future goals. This shows your genuine interest in the role and helps you assess if the company aligns with your career aspirations.
