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- Tasks: Lead regulatory strategy and ensure quality compliance for innovative diagnostic products.
- Company: Join a pioneering diagnostics company making a real-world impact in healthcare.
- Benefits: Enjoy a collaborative work environment with hands-on responsibilities and growth opportunities.
- Why this job: Shape the future of diagnostics while working with a mission-driven team.
- Qualifications: 5-7 years in Regulatory and Quality roles, with experience in IVD and FDA submissions.
- Other info: Reach out to ellen.stanton@hartmannyoung.com to apply or learn more!
The predicted salary is between 43200 - 72000 £ per year.
Hartmann Young is partnered with an innovative and established diagnostics company, seeking a Senior Manager of Regulatory Affairs & Quality Assurance to lead and execute regulatory strategy and quality systems compliance. This is a high-impact, hands-on leadership role suited to someone who thrives in a position with roll-up-your-sleeves operational responsibilities.
We’re looking for someone collaborative, who has proven experience navigating both FDA and IVDR regulatory environments in the in vitro diagnostics (IVD) space.
Key responsibilities:- Lead, maintain, and continuously improve the company’s Quality Management System (QMS) in compliance with both IVDR, and eventually FDA standards.
- Drive regulatory strategy for current and future IVD products, ensuring successful product registrations and post-market compliance.
- Serve as primary contact for regulatory bodies, notified bodies, and auditors.
- Prepare and submit regulatory dossiers (510(k), Technical Files, etc.).
- Collaborate closely with R&D, Operations, and Clinical teams to ensure regulatory and quality requirements are embedded across product development and lifecycle.
- Provide hands-on support for document control, design history files, validation protocols, and day-to-day RA/QA activities.
- Minimum 5–7 years in Regulatory and Quality roles in the IVD, medical device, or molecular diagnostics industry.
- Solid understanding and working experience with IVDR and EU regulatory frameworks.
- Proven experience with FDA regulatory submissions (e.g., 510(k)) and compliance audits.
- Hands-on mindset; someone who enjoys doing the work as much as guiding or managing a team.
You’ll join a mission-driven team developing diagnostic solutions that make a real-world impact. You’ll have the chance to shape quality and regulatory operations in a meaningful, collaborative way.
If this sounds like you, reach out on ellen.stanton@hartmannyoung.com or apply directly below. We’d love to hear from you!
Senior Manager of Regulatory and Quality - Diagnostics employer: Hartmann Young
Contact Detail:
Hartmann Young Recruiting Team
ellen.stanton@hartmannyoung.com
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager of Regulatory and Quality - Diagnostics
✨Tip Number 1
Network with professionals in the diagnostics field, especially those who have experience with FDA and IVDR regulations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and quality management systems relevant to the IVD space. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role's requirements.
✨Tip Number 3
Prepare to discuss your hands-on experience in managing regulatory submissions and quality assurance processes. Be ready to share specific examples of how you've successfully navigated compliance audits or improved quality systems in previous roles.
✨Tip Number 4
Showcase your collaborative skills by highlighting past experiences where you worked closely with cross-functional teams. Emphasise your ability to integrate regulatory and quality requirements into product development, as this is crucial for the role.
We think you need these skills to ace Senior Manager of Regulatory and Quality - Diagnostics
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs and Quality Assurance, particularly within the IVD or medical device sectors. Emphasise your hands-on experience with FDA submissions and IVDR compliance.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for diagnostics and your collaborative approach. Mention specific examples of how you've successfully navigated regulatory environments and improved quality management systems in previous roles.
Highlight Relevant Skills: In your application, clearly outline your skills related to regulatory strategy, quality management systems, and cross-functional collaboration. Use keywords from the job description to ensure your application stands out.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Hartmann Young
✨Showcase Your Regulatory Knowledge
Make sure to highlight your experience with FDA and IVDR regulations during the interview. Be prepared to discuss specific examples of how you've navigated these regulatory environments in past roles, as this will demonstrate your expertise and suitability for the position.
✨Emphasise Collaboration Skills
Since the role requires close collaboration with various teams, be ready to share examples of how you've successfully worked with R&D, Operations, and Clinical teams in the past. This will show that you can foster teamwork and ensure regulatory and quality requirements are met throughout product development.
✨Prepare for Hands-On Scenarios
Expect questions that assess your hands-on approach to regulatory affairs and quality assurance. Prepare to discuss specific tasks you've undertaken, such as preparing regulatory dossiers or managing document control, to illustrate your operational capabilities.
✨Demonstrate Continuous Improvement Mindset
The company is looking for someone who can lead and improve their Quality Management System. Be ready to talk about initiatives you've implemented in previous roles that enhanced compliance or efficiency, showcasing your commitment to continuous improvement in regulatory and quality processes.
