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- Tasks: Lead global quality and regulatory strategy for innovative medical devices.
- Company: Join a pioneering global medical device company transforming healthcare technology.
- Benefits: Enjoy a full-time role with opportunities for professional growth and leadership.
- Why this job: Shape the future of medical technologies while driving quality excellence globally.
- Qualifications: Proven leadership in QARA, strong engineering background, and expertise in compliance standards.
- Other info: Ideal for experienced professionals ready to influence at a senior level.
The predicted salary is between 72000 - 108000 £ per year.
Director of Quality Assurance & Regulatory Affairs
Cure Talent are delighted to be partnered with a global medical device company at the forefront of developing advanced technologies that support clinicians and healthcare providers worldwide. As they continue to expand their innovative portfolio and international presence, we have an exciting opportunity for a Director of Quality Assurance & Regulatory Affairs to join their UK leadership team.
As the Director of QARA, you will play a pivotal role in shaping and delivering the company’s global quality and regulatory strategy. This is a senior leadership position with responsibility for ensuring compliance across a diverse product portfolio, enabling market access, and embedding quality excellence throughout the product lifecycle.
To be successful as the Director of QARA, you will be an experienced medical device professional with proven leadership in Quality Assurance and Regulatory Affairs. You will bring a strong engineering background, expertise in ISO 13485, MDR and FDA compliance, and a track record of managing international submissions and inspections. Alongside your technical knowledge, you will be a confident communicator with the ability to influence at senior level, develop teams, and embed a culture of compliance and continuous improvement.
Key Responsibilities
- Lead and implement the company’s global QARA strategy in line with business and compliance objectives.
- Oversee international product registrations, submissions, CE marking and approvals.
- Maintain and continuously improve the Quality Management System to ISO 13485, MDR and FDA standards.
- Host regulatory inspections and lead internal and supplier audit programmes.
- Mentor and develop the QARA team, embedding a culture of compliance and continuous improvement.
Experience and Skills Required
- Proven leadership in Quality Assurance and Regulatory Affairs within medical devices or regulated industries.
- Strong engineering background with expertise in CE marking, EU/UK MDR, FDA and international submissions.
- Hands-on experience with audits, inspections and QMS management.
- Skilled in electrical safety, software validation and global compliance requirements.
- Excellent communication, stakeholder engagement and team development skills.
If you’re an experienced QARA leader ready to shape the regulatory future of innovative medical technologies and drive quality excellence on a global scale, we’d love to hear from you.
Job Details
- Seniority level: Director
- Employment type: Full-time
- Job function: Quality Assurance, Engineering, and Legal
- Industries: Medical Equipment Manufacturing
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Director Quality Assurance Regulatory Affairs employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Quality Assurance Regulatory Affairs
✨Tip Number 1
Network with professionals in the medical device industry, especially those who have experience in Quality Assurance and Regulatory Affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485, MDR, and FDA compliance. Being able to discuss these topics confidently during interviews will demonstrate your expertise and commitment to the role.
✨Tip Number 3
Prepare examples from your past experiences that showcase your leadership skills and ability to manage teams effectively. Highlight instances where you successfully implemented quality management systems or led regulatory submissions, as these will be key points of interest for the hiring team.
✨Tip Number 4
Research the company’s current product portfolio and any recent news related to their innovations. This knowledge will not only help you tailor your discussions but also show your genuine interest in the company and its mission during the interview process.
We think you need these skills to ace Director Quality Assurance Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Quality Assurance and Regulatory Affairs, particularly within the medical device sector. Emphasise your leadership roles and any specific achievements related to ISO 13485, MDR, and FDA compliance.
Craft a Compelling Cover Letter: In your cover letter, clearly articulate your vision for the QARA strategy and how your background aligns with the company's goals. Use specific examples from your past experiences to demonstrate your ability to lead teams and manage compliance effectively.
Highlight Relevant Skills: Ensure you mention key skills such as stakeholder engagement, team development, and your hands-on experience with audits and inspections. These are crucial for the role and should be evident in both your CV and cover letter.
Showcase Communication Abilities: As a senior leader, your communication skills are vital. Provide examples of how you've influenced senior stakeholders or led teams in previous roles. This will help convey your capability to mentor and develop others in the QARA field.
How to prepare for a job interview at Cure Talent
✨Showcase Your Leadership Experience
As a Director of Quality Assurance & Regulatory Affairs, your leadership skills are crucial. Be prepared to discuss specific examples of how you've led teams, managed projects, and influenced stakeholders in previous roles.
✨Demonstrate Technical Expertise
Familiarise yourself with ISO 13485, MDR, and FDA compliance standards. Be ready to explain how your engineering background has equipped you to handle regulatory submissions and inspections effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think of scenarios where you had to navigate complex regulatory challenges or improve quality management systems.
✨Emphasise Continuous Improvement
Discuss your approach to embedding a culture of compliance and continuous improvement within teams. Share examples of initiatives you've implemented that have led to enhanced quality outcomes.
