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, 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 the MedTech industry while shaping the future of healthcare.
- Qualifications: Experience in Quality & Regulatory functions within the medical device sector 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 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 reflected in our supportive culture, where you will have the opportunity to lead a dynamic team and shape the future of hearing healthcare. With competitive benefits and a focus on work-life balance, we empower our employees to thrive both personally and professionally while making a meaningful impact in the MedTech industry.
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 people in the medical device industry, especially those who have experience with QARA roles. Use LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA regulations and ISO standards. Be ready to discuss how you've successfully navigated regulatory pathways in the past. Show them you're not just a candidate, but the right candidate!
✨Tip Number 3
Don’t forget to showcase your leadership skills! As a Head of QARA, you'll need to demonstrate how you've built and scaled teams before. Share specific examples of how you've led teams to success in previous roles.
✨Tip Number 4
Apply through our website! We make it easy for you to find and apply for jobs that match your skills. Plus, it shows you're serious about joining our innovative team in transforming healthcare access.
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 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 and EU regulatory pathways, and how you've successfully led teams in the past.
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements! Quantify your successes where possible, like how you improved compliance or led successful audits. We love seeing numbers that back up your claims!
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 any important updates from us!
How to prepare for a job interview at United Cerebral Palsy of Georgia
✨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 Head of QARA, you'll need to demonstrate your ability to lead and develop a team. Prepare examples from your past experiences where you've successfully built or scaled a function, and how you managed to maintain compliance while driving performance.
✨Prepare for Technical Questions
Expect to be asked about specific regulatory pathways, like achieving FDA clearance or CE marking. Be ready to discuss your previous experiences with these processes, including any challenges you faced and how you overcame them.
✨Engage with the Company’s Vision
Research the company’s mission and recent developments in ear and hearing healthcare technology. Showing that you understand their goals and how your role fits into their vision will set you apart as a candidate who is genuinely interested in contributing to their success.
