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- 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, leadership role, and the chance to shape the future of healthcare.
- Other info: Opportunity to grow in a dynamic environment with global reach.
- Why this job: Make a real impact in the MedTech industry while leading a passionate team.
- Qualifications: Experience in Quality & Regulatory functions within the medical device sector is essential.
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 QARA employer: Cure Talent Ltd
Contact Detail:
Cure Talent Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of QARA
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Head of QARA role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and EU regulations. We want you to be the go-to expert in the room, so practice articulating your experience with regulatory pathways and quality management systems.
✨Tip Number 3
Showcase your leadership skills! When discussing your past roles, highlight how you’ve built and scaled teams in the MedTech space. We’re looking for someone who can inspire and lead the QARA function effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. We’re excited to see how you can contribute to transforming ear and hearing healthcare!
We think you need these skills to ace Head of QARA
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 key responsibilities outlined 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 how you've successfully navigated regulatory pathways and led teams in a MedTech environment. We love a good story!
Showcase Your Achievements: Don’t just list your duties; showcase your achievements! Quantify your successes where possible, like the number of successful FDA submissions or improvements made to quality management systems. We’re all about results here at StudySmarter!
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. Plus, it’s super easy!
How to prepare for a job interview at Cure Talent Ltd
✨Know Your Regulations Inside Out
Make sure you brush up on the latest regulations and standards like ISO 13485, FDA 21 CFR Part 820, and EU MDR. 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 Your Problem-Solving Abilities
Be ready to discuss specific challenges you've faced in regulatory submissions or quality management systems. Share how you tackled these issues and what the outcomes were, as this will illustrate your hands-on leadership style.
✨Engage with the Interviewers
Don't forget that interviews are a two-way street! Prepare thoughtful questions about the company's growth plans and how the QARA function fits into their strategy. This shows your genuine interest and helps you assess if it's the right fit for you.