We are thrilled to introduce two new members of the LFH Regulatory team who bring a wealth of expertise and passion to their roles. Please join us in welcoming Alexander Madell, our new Quality Assurance and Regulatory Affairs Consultant, and Faiza Jabeen, our new Senior Regulatory Affairs Consultant. With their extensive experience and enthusiasm for the regulatory field, they are set to make a significant impact, supporting both our clients and the continued growth of LFH Regulatory.
Alexander Madell – Quality Assurance and Regulatory Affairs Consultant
What Will Your Role Entail?
As a Quality Assurance and Regulatory Affairs Consultant, Alexander will be working closely with external clients to provide a comprehensive range of support, from drafting technical files for medical devices to implementing new Quality Management Systems (QMS). He will also act as the UK Responsible Person (UKRP) for businesses outside the UK, helping them bring their medical device products to the UK market. Alexander’s role will cover a broad spectrum of Quality Assurance and Regulatory Affairs challenges, ensuring clients remain compliant with evolving regulations.
What Are You Most Excited About Joining the LFH Regulatory Team?
“I’m thrilled to be joining a growing business that offers such a variety of work,” says Alexander. “At LFH, I’ll have the chance to support a diverse range of clients and help develop the business further. Having previously worked in larger organisations, the opportunity to be part of a more dynamic, flexible team where I can make a tangible impact really excites me. I can’t wait to get started!”
What Do You Love About the Regulation Industry?
“While it’s not something most people dream of doing, the regulatory industry is incredibly dynamic and fast-paced,” Alexander explains. “The constant evolution of technology keeps things interesting, and I love being able to leverage my science background to help bring safer, more effective products to market. The regulatory field provides endless opportunities for learning and problem-solving, which is something I truly enjoy.”
What Are Some of the Challenges You Face in Your Role?
“Regulatory roles have often been seen as obstacles to business success, the dreaded ‘red tape’,” Alexander acknowledges. “But I believe the industry is changing. More businesses are recognising the need for robust, effective regulation to ensure safety without being overly burdensome. Gaining buy-in from other departments is becoming easier as organisations see the value in compliance.”
Tell Us Something People May Not Know About You?
“I finished school in Australia before moving back to the UK for university. I originally planned to return to Australia, but life had other plans,” says Alexander. “I reconnected with someone I’d known since I was five, and we’re now happily married. So, I’ve settled back in Essex, where I started, and I haven’t looked back since!”
Faiza Jabeen – Senior Regulatory Affairs Consultant
What Will Your Role Entail?
Faiza will be focused on addressing the regulatory needs of LFH’s diverse client base. Her role includes developing regulatory strategies, creating vital regulatory documents, and leading discussions with regulatory authorities on behalf of clients. Faiza’s work will ensure that clients’ products meet all necessary regulatory requirements, facilitating safe and effective solutions for the market.
What Are You Most Excited About Joining the LFH Regulatory Team?
“The variety of work is one of the most exciting aspects of joining LFH,” says Faiza. “I’ll be working on a wide range of products, helping to turn innovative ideas into real-world solutions. It’s incredibly rewarding to be part of that process.”
What Do You Love About the Regulation Industry?
Faiza’s passion for the regulatory field is evident: “It might surprise people, but I genuinely love my job,” she admits. “What I find so satisfying is knowing that my work helps create products that are safe and effective, ultimately improving people’s lives. The regulatory landscape is always changing, so there’s always something new to learn. This keeps my work dynamic and fulfilling.”
What Are Some of the Challenges You Face in Your Role?
“A major challenge I’ve faced is ensuring that the importance of regulatory adherence is understood throughout the entire organisation,” Faiza explains. “Regulation is sometimes seen as a hurdle, but it’s essential for ensuring safety and compliance. My goal is to help make sure that regulatory priorities are understood and embraced by all teams, not just seen as a burden.”
Tell Us Something People May Not Know About You?
When it comes to her personal interests, Faiza shares, “My love language is food! I love to cook. Whether it’s experimenting with new recipes or preparing meals for my family, it’s something I really enjoy. It’s a great way for me to unwind and recharge.”
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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