At a Glance
- Tasks: Lead quality assurance and regulatory compliance for innovative cancer diagnostics.
- Company: Global leader in cancer diagnostics focused on improving patient outcomes.
- Benefits: Competitive salary, relocation support, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to advancing diagnostic innovation.
- Why this job: Make a real impact in the fight against cancer through quality and compliance leadership.
- Qualifications: 15+ years in medical device or diagnostics quality assurance with strong leadership skills.
The predicted salary is between 80000 - 120000 £ per year.
Do you want to shape the quality and regulatory strategy behind life-changing cancer diagnostics? Are you ready to lead a global Quality Assurance and Regulatory Compliance organisation within a highly regulated diagnostics environment? Do you enjoy driving operational excellence, innovation, and compliance across complex global product portfolios?
Fraser Dove International is partnering exclusively with a global cancer diagnostics organisation. Operating internationally, they are committed to advancing diagnostic innovation that improves patient outcomes and accelerates access to life-changing therapies. Our client is seeking a strategic leader to oversee Quality Assurance and Regulatory Compliance activities across a growing portfolio of advanced diagnostic products and companion diagnostics.
Your objectives:
- Drive quality assurance and regulatory compliance strategies that support innovation, operational excellence, and business growth across the diagnostics portfolio.
- Strengthen quality management systems (QMS), governance, and compliance performance while maintaining regulatory integrity and product quality standards.
- Build and develop a high-performing quality organisation that promotes collaboration, accountability, continuous improvement, and future leadership capability.
What you will do:
- Develop and execute strategic quality and compliance initiatives across advanced diagnostics and companion diagnostic products.
- Partner with senior leaders across Regulatory Affairs, Clinical Affairs, Medical Affairs, and operational teams to align quality objectives with business priorities.
- Lead and oversee Quality Assurance and Regulatory Compliance performance, including quality systems, product quality, issue resolution, and compliance activities.
- Drive operational excellence through continuous improvement initiatives, process optimisation, and forward-looking quality strategies.
- Provide leadership across global quality management initiatives, including KPI tracking, governance, and cross-site collaboration activities.
- Manage departmental budgets, resource allocation, timelines, and organisational priorities to support business objectives.
- Develop and mentor managers and senior professionals, fostering a culture of quality, compliance, innovation, and accountability.
What you will bring:
- 15+ years of progressive experience within medical device, diagnostics, or in vitro diagnostics (IVD) Quality Assurance environments.
- Proven leadership experience managing large, complex quality or regulatory organisations within highly regulated global businesses.
- Strong experience leading quality and compliance initiatives that enable innovation, operational excellence, and business growth.
- Deep technical knowledge of diagnostic technologies including molecular methods, protein-based assays, imaging, and companion diagnostics.
- Exceptional communication, stakeholder management, and influencing skills across global cross-functional teams and senior leadership groups.
- Bachelor’s degree in a scientific, medical, or technical discipline.
- Advanced degree or postgraduate qualification preferred.
Got what it takes? To apply for the Senior Director, Quality Assurance & Regulatory Compliance, click the ‘Apply’ button below or contact the Executive Search Consultant – (REECE WIGGINS) – on +44 (0).
Director, Regulatory Data employer: Fraser Dove International
Join a pioneering global cancer diagnostics organisation that is dedicated to advancing diagnostic innovation and improving patient outcomes. With a strong commitment to operational excellence and compliance, the company fosters a collaborative work culture that encourages continuous improvement and professional growth. Employees benefit from a supportive environment that values leadership development and offers unique opportunities to make a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Regulatory Data
✨Tip Number 1
Network like a pro! Reach out to industry contacts and 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 dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We want you to be able to discuss how your experience aligns with their goals in quality assurance and regulatory compliance. Show them you’re the perfect fit!
✨Tip Number 3
Practice your pitch! We suggest you rehearse how you’ll present your skills and experiences. Make sure you can clearly articulate how you can drive operational excellence and innovation in their diagnostics portfolio.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re here to help you every step of the way, so let’s get you that Senior Director role!
We think you need these skills to ace Director, Regulatory Data
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in quality assurance and regulatory compliance. We want to see how your background aligns with the specific objectives of the role, so don’t hold back on showcasing your relevant skills!
Showcase Leadership Experience:Since this is a senior director position, it’s crucial to emphasise your leadership experience. We’re looking for someone who can build and develop high-performing teams, so share examples of how you’ve successfully led teams in the past.
Highlight Technical Knowledge:Don’t forget to mention your technical expertise in diagnostic technologies. We want to know about your familiarity with molecular methods, protein-based assays, and other relevant areas, as this will set you apart from other candidates.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Fraser Dove International
✨Know Your Stuff
Make sure you brush up on the latest trends and regulations in the diagnostics field. Familiarise yourself with the specific technologies mentioned in the job description, like molecular methods and protein-based assays. This will show that you're not just a leader but also someone who understands the technical side of things.
✨Showcase Your Leadership Skills
Prepare examples of how you've built high-performing teams and driven operational excellence in previous roles. Think about specific initiatives you've led that resulted in improved compliance or quality outcomes. This will help demonstrate your capability to lead a global Quality Assurance and Regulatory Compliance organisation.
✨Align with Business Objectives
Be ready to discuss how you can align quality assurance strategies with business growth. Think about how you've partnered with other departments in the past, like Regulatory Affairs or Clinical Affairs, to achieve common goals. This shows that you understand the bigger picture and can drive collaboration.
✨Ask Insightful Questions
Prepare thoughtful questions that reflect your understanding of the company's mission and challenges. For instance, ask about their current quality management systems or how they measure success in regulatory compliance. This not only shows your interest but also your strategic thinking.
