Job Description
Regulatory Director / Senior Regulatory Director
Location: South of UK (Hybrid/Flexible)
Salary: £90,000 - £120,000 (flexible for exceptional candidates), plus bonus and matched pension
Our client, a fast-growing scale-up developing complex diagnostic instruments/systems, is seeking a Regulatory Affairs Director / Senior Director.
This role offers a blend of in-person collaboration at their state-of-the-art facility in the South of UK, combined with the flexibility of hybrid working arrangements.
What You'll Bring
* Ambition to build the best QARA team in the world within 3-5 years
* Energy to overcome inertia and drive initiatives forward
* Experience AND imagination to apply standard approaches and create innovative solutions
* Ability to identify, quantify, and manage risk effectively
* A can-do attitude and positive approach to problem-solving
* Hands-on leadership style, willing to guide and support the team directly
Why This Opportunity Stands Out
* Innovation at the Core : Work with world-class scientists, engineers, and business leaders on incredibly complex and diverse technologies
* Global Impact : Influence how their technology advances scientific understanding and improves health outcomes
* Career Progression : Potential to oversee both Regulatory Affairs and Quality Assurance in the future
* Work Environment : Collaborate in a state-of-the-art office at a renowned science park, with the flexibility of hybrid working
What's On Offer
* Competitive salary range of £90,000 - £120,000, with flexibility for exceptional candidates
* Bonus scheme
* Matched pension contributions
* Opportunity to join a large, profitable company with the growth potential of a start-up
* Chance to work on ground-breaking products for global markets
* Hybrid working model, balancing in-person collaboration with flexibility
About Our Client
This cutting-edge company has developed a groundbreaking analytical technology platform. Their innovative solution is unique in offering real-time analysis, from portable devices to large-scale applications. They're transforming their field, making advanced scientific analysis accessible to researchers, healthcare professionals, and scientists across diverse disciplines.
The Role
Reporting to the Global VP of RA/QA, who is on a mission to build the best RA/QA team in the industry, you will:
* Manage regulatory, risk management, post-market surveillance, and clinical affairs functions
* Lead regulatory strategy for cutting-edge platforms transforming scientific analysis and diagnostics worldwide
* Navigate EU IVDR and USA/510(k) submissions
* Shape industry standards as the company pushes the boundaries of what's possible in their field
* Build and lead a scientifically oriented team, bringing in a crucial engineering perspective
What We're Looking For
* A strategic thinker with ambition, energy, and a passion for science
* Extensive experience in regulatory affairs for medical devices or diagnostics (IVDR)
* Strong leadership skills to build, inspire, and energize a team
* Experience with global product approvals, including 510(k) and CE marking
* High-energy, solutions-oriented approach with an appetite for calculated risk
* Deep technical understanding, particularly in areas such as software, electronics, and engineering
* Expertise in at least two of the following areas:
* IEC 62304 (Medical device software life cycle processes)
* IEC 62366 (Usability engineering for medical devices)
* GLP (Good Laboratory Practice)
* EMC (Electromagnetic Compatibility)
* Ability to communicate complex regulatory requirements simply and effectively
* Commercial awareness and understanding of how regulatory affairs add value to the business
* IVD instruments/systems experience is highly valuable - applications from professionals with a strong background in related fields within electro-mechanical and software medical technology standards will also be considered
This is a unique chance to join a company at the forefront of biotechnological innovation. You'll be working with a team that's not just successful, but truly meaningful – their technology has applications ranging from fundamental scientific research to addressing global health challenges.
If you're excited about turning cutting-edge science into real-world solutions, and you have the regulatory expertise to help do it responsibly and effectively, we want to hear from you.
We encourage all interested candidates to apply or reach out for a confidential discussion, even if your experience or current compensation is outside the stated range.
For a confidential discussion about this exceptional opportunity, please contact Josh Craven at Indo Search.