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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, career growth opportunities, and a chance to make a real impact.
- Other info: Dynamic start-up environment with opportunities to lead and develop a growing team.
- Why this job: Be at the forefront of medical innovation and shape the future of healthcare.
- Qualifications: Experience in Quality & Regulatory functions 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.
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.
Executive Chef - English Speaking in London employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Executive Chef - English Speaking in London
✨Tip Number 1
Network like a pro! Reach out to industry contacts, attend relevant events, and join online forums. The more people you know in the medical device space, the better your chances of landing that Executive Chef role.
✨Tip Number 2
Showcase your expertise! Prepare a portfolio or presentation that highlights your experience with FDA approvals and quality management systems. This will help you stand out during interviews and demonstrate your hands-on leadership skills.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors who understand the MedTech industry. This will help you refine your answers and boost your confidence when discussing regulatory pathways and compliance.
✨Tip Number 4
Apply through our website! We make it easy for you to find and apply for roles like this one. Plus, it shows you're serious about joining our innovative team in transforming ear and hearing healthcare.
We think you need these skills to ace Executive Chef - English Speaking in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Executive Chef role. Highlight your experience in leading Quality & Regulatory functions and any specific achievements in the medical device industry. We want to see how your background aligns with what we're looking for!
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. Mention your proven experience with FDA approvals and your ability to scale teams in a growing MedTech environment. Let us know what excites you about this opportunity!
Showcase Relevant Skills: In your application, make sure to showcase skills that are relevant to the role, like your knowledge of ISO 13485 and experience with audits. We’re looking for someone who can hit the ground running, so don’t hold back on your expertise!
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 out on any important updates. Plus, it’s super easy to do!
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 compliance.
✨Showcase Your Leadership Skills
As this role involves leading a team, be prepared to share examples of how you've successfully built and developed teams in the past. Highlight specific challenges you've faced and how you overcame them, demonstrating your hands-on leadership style.
✨Prepare for Technical Questions
Expect to dive deep into technical discussions about regulatory pathways and submissions. Brush up on your experience with FDA 510(k) and EU MDR approvals, and be ready to explain your approach to managing audits and inspections.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions that show your interest in the company’s growth and future. Inquire about their plans for scaling the QARA function or how they handle compliance challenges in a rapidly changing environment.