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- Tasks: Lead global quality and regulatory strategy for medical devices.
- Company: Join a diverse and inclusive company dedicated to high standards in healthcare.
- Benefits: Enjoy a competitive salary of £85K plus benefits and flexible working options.
- Why this job: Make a real impact on product quality and compliance while mentoring a dynamic team.
- Qualifications: Proven leadership in QARA, strong engineering background, and experience with regulatory submissions required.
- Other info: We welcome applications from all backgrounds and support candidates with disabilities.
The predicted salary is between 68000 - 102000 £ per year.
Position: Director of Quality Assurance & Regulatory Affairs Location: Middlesex Salary: £85K + benefits Purpose of the Role To lead global quality and regulatory strategy, ensuring compliance across the company\’s product portfolio. This role is pivotal in enabling market access, maintaining high standards, and embedding quality throughout the product lifecycle. Strategic Leadership Represent role model or servant leader model leadership as a member of senior site management team. Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements. Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery. Represent the company in regulatory compliance audits and external engagements.Regulatory Affairs Oversee global product registrations and submissions, including CE marking and international approvals for company products Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification. Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.Quality Assurance Maintain and enhance the Quality Management System (QMS). Lead internal and supplier audits, investigations, and corrective actions. Analyse QA data to drive continuous improvement and risk mitigation.Project Oversight Lead QARA team in managing regulatory documentation and audit readiness. Support change control and post-market surveillance activities.Team Development Mentor and develop QARA team members. Ensure training programmes reflect current regulatory and quality practices. Skills & Experience Proven leadership in QARA within medical devices or regulated industries. Strong engineering background Experience with CE marking, Medical Device Requirements, both EU and UK, regulatory submissions, electrical safety requirements, software validation, and international compliance. Excellent communication and stakeholder engagement skills. Familiarity with electronic QMS and project management tools.Desirable Qualifications Degree in Engineering, Life Sciences, or related field (Master\’s preferred). Experience working directly with regulatory bodies. Lead Auditor Certification About Us We are dedicated to fostering a diverse and inclusive community. In line with our Diversity and Inclusion policy, we welcome applications from all qualified individuals, regardless of age, gender, ethnicity, sexual orientation, or disability. As a Disability Confident Employer, and part of the Nicholas Associates Group, we are committed to supporting candidates with disabilities, and we\’re happy to discuss flexible working options. We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Nicholas Associates Group of companies
Director of Quality Assurance employer: Nicholas Associates
Contact Detail:
Nicholas Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Quality Assurance
✨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 and MDR. Being able to discuss these in detail during interviews will demonstrate your expertise and commitment to compliance.
✨Tip Number 3
Prepare to showcase your leadership skills by gathering examples of how you've successfully led teams or projects in the past. Highlight your ability to mentor others and drive continuous improvement within a quality management system.
✨Tip Number 4
Research StudySmarter's values and culture to align your approach during interviews. Understanding our commitment to diversity and inclusion can help you articulate how you would contribute to fostering an inclusive environment within the team.
We think you need these skills to ace Director of Quality Assurance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your leadership experience in Quality Assurance and Regulatory Affairs, particularly within the medical devices sector. Emphasise relevant skills such as compliance with ISO 13485 and experience with CE marking.
Craft a Compelling Cover Letter: In your cover letter, demonstrate your understanding of the company's goals and how your strategic leadership can align with their QARA strategy. Use specific examples from your past experiences to illustrate your capabilities.
Highlight Relevant Qualifications: Clearly list your qualifications, especially your degree in Engineering or Life Sciences, and any certifications like Lead Auditor Certification. Mention any direct experience with regulatory bodies to strengthen your application.
Showcase Communication Skills: Since excellent communication is crucial for this role, provide examples of how you've successfully engaged stakeholders in previous positions. This could include leading audits or collaborating with cross-functional teams.
How to prepare for a job interview at Nicholas Associates
✨Showcase Your Leadership Skills
As a Director of Quality Assurance, demonstrating your leadership style is crucial. Be prepared to discuss your experience in leading teams, particularly in regulated environments, and how you embody a servant leader model. Share specific examples of how you've mentored team members and driven strategic initiatives.
✨Understand Regulatory Frameworks
Familiarise yourself with the key regulatory standards relevant to the role, such as ISO 13485 and MDR. Be ready to discuss your experience with CE marking and international compliance. This will show that you have the necessary knowledge to oversee global product registrations effectively.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in quality assurance. Think about past challenges you've faced, how you approached them, and the outcomes. This will demonstrate your analytical abilities and commitment to continuous improvement.
✨Engage with Stakeholders
Highlight your communication skills by discussing how you've engaged with various stakeholders, including engineering and operations teams. Prepare to share examples of successful collaborations that led to improved quality and compliance outcomes, showcasing your ability to integrate quality throughout the product lifecycle.
