Meet the Team
Introduction
Your trusted partners for regulatory and quality excellence
At BaxMed Regulatory Ltd, we believe that effective regulatory and quality consulting starts with the right people.
When you partner with one of our consultants, you benefit from the collective knowledge and expertise of our entire team – boasting over 100 years of combined experience in regulatory affairs, quality systems, and product development for medical devices and in vitro diagnostics (IVDs).
experience
Supporting your compliance challenges
Our team has a proven track record of securing global approvals, streamlining operations, and guiding clients through complex compliance challenges. Whether it’s navigating EU MDR/IVDR, FDA 510(k), PMA submissions, or implementing Quality Management Systems, we’re here to help you succeed.
Stuart Baxter
CEO & Principal Consultant
With over 15 years in the medical diagnostics industry, Stuart brings deep regulatory and technical expertise to every client engagement. His experience spans regulatory strategy, quality system implementation, and hands-on development of technical and clinical documentation across diverse product types.
Known for his calm, meticulous approach, Stuart leads the BaxMed team with a focus on excellence, collaboration, and actionable results.
Niki Skelly
Director of Regulatory Affairs
Niki is a Regulatory Affairs and Quality Management professional with 19+ years of global experience. She has led successful product registrations across Europe, the US, Japan, and China and is a certified Lead Auditor in ISO13485 and ISO9001. With deep knowledge of international standards and a reputation for finding solutions to the most complex compliance challenges, Niki integrates effortlessly into teams and helps them achieve regulatory success with clarity and confidence.
Senior Regulatory Affairs Consultant
With a Ph.D. in immunoassay development and over 25 years in the IVD industry, this consultant brings unmatched technical and regulatory insight. An expert who has held leadership roles in globally recognized diagnostics companies, they specialize in global regulatory submissions, risk management, and QMS implementation. Their strategic thinking makes them a key asset in supporting innovation and compliance for complex IVD products
Quality Assurance Consultant
With over 15 years of experience enhancing quality systems across life sciences, our QA Consultant brings strategic thinking and practical know-how to every engagement. From CAPA and audit systems to eQMS implementation and manufacturing excellence, she is known for her collaborative, results-driven style and her ability to resolve even the most difficult quality challenges with a “right-first-time” mindset.
Nichola McGeough
Director of Business Operations
Nichola is the driving force behind BaxMed’s commercial growth, bringing extensive experience in life sciences operations, client acquisition, and market strategy.
With a global network and strong sector knowledge, she supports startups and scale-ups through regulatory readiness and operational scaling.
Nichola also leads HR, digital marketing, event strategy, and talent development, ensuring a thriving internal culture and exceptional client experience.
Cindy Hornby
Business Support Associate
Cindy plays a key role in amplifying BaxMed’s brand through strategic social media and marketing. With a focus on engagement and visibility, she manages content across platforms and supports business development through client outreach and relationship management.
Cindy’s attention to detail and creative communication style makes her an integral part of the company’s outward-facing team.
Contact
Get in touch
Contact us today to learn more about how BaxMed Regulatory Ltd can empower your organisation to thrive in a highly regulated environment. Together, we can turn regulatory and quality challenges into opportunities for growth and innovation.