| This article is part of our 5 Questions With series, one of our ongoing People & Places Features. We love it because despite the consistent questioning, the answers are all unique. Be sure to FOLLOW us on LinkedIn to tell us what you think. |
1. Please introduce yourself to our audience by looking back at your education, training, and career path.
Hello there! I’m Monica Magnardini, a senior consultant for PQE Group. I’m based in Italy, specifically in Milan. I obtained my degrees in Biomedical Engineering by first attending the University of Pavia and then the Campus Bio-Medico in Rome. After graduation, I immediately started working for PQE, gaining experience for a year in Computer System Validation. In the following years, the training I received on Software as Medical Devices and quality systems compliance with international standards has prepared me to make a meaningful impact in the healthcare industry. In recent times, my training has shifted towards understanding the regulatory aspects that concern issues that are becoming increasingly important in recent years, such as cybersecurity and artificial intelligence.
2. Can you share more about your specific role at PQE Group? What are your main goals in this role, and what’s your favorite part about your job?
As a senior consultant, my work focuses on different parts: firstly I must be able to manage the work assigned to me autonomously, and at the same time I must be able to execute critical thinking, understand the main issues beneath a problem and solve them with no strict supervision. Also, one of my objectives is to train, delegate, and review the work of my colleagues.
Working at PQE has provided me with the opportunity to learn things that unfortunately were not considered important in my university studies. Additionally, I have been able to engage with various companies to assist them in marketing innovative products. Besides my team, which is one of the reasons I enjoy this work, my favorite part is definitely when the project is completed and the customer is satisfied with the work we have done for them. Achieving the desired result is the most fulfilling aspect of my current work.
3. Can you tell us more about why companies should consider partnering with PQE Group and what type of services you offer to your clients?
PQE Group is a renowned consulting firm specializing in quality solutions for the life sciences industry. Companies should consider partnering with PQE Group for several reasons, including the fact that the range of services it offers clients is comprehensive and customized to meet the specific needs of the life sciences sector. In fact, PQE Group offers a full spectrum of services from quality assurance to regulatory compliance, ensuring all aspects of a company’s needs are addressed and the services are tailored to fit the specific requirements of each client, ensuring personalized and effective solutions.
I can support customers through the entire Medical Device regulatory lifecycle, providing a full range of regulatory activities. Our service begins with the development of the regulatory strategy and concludes with the editing, amendment, and submission of the necessary documents both according MDR and FDA. Also, I’m able to support medical device companies when they are developing Software as Medical Devices (SaMD) helping them with the software classification, the definition of the risk assessment and cybersecurity risk assessment, and compliance with IEC 62304 standard.
4. Consulting is becoming a popular career path, particularly for scientists and medical professionals. What, in your opinion, are the top skills needed to be successful in a life science-focused consulting role?
To succeed in a life science-based consulting role, it is crucial to possess several key skills. You must have a deep understanding of the subject matter you are advising on, such as medical devices or in vitro diagnostics. Staying updated with the latest scientific research, technological developments, and industry trends is also essential. Effective communication is another vital skill. As a consultant, you need to communicate ideas and recommendations, both in writing and verbally, to clients and stakeholders. Additionally, the ability to establish rapport and maintain strong relationships with clients and team members is important. Connected to the relationship with the customer, it is also necessary to have a client-focused mindset centered on two different aspects: client engagement, the ability to identify client needs, and flexibility in work with additional clients at the same time.
Developing and honing these skills can significantly enhance the effectiveness and success of a consultant in the life sciences sector, enabling them to provide high-value insights and solutions to their clients.
5. Now for the fun question – what is the best piece of advice that you’ve ever been given?
One piece of advice I was given, and that I recommend to new employees when they join the company, is to ask questions. No question is stupid or useless. If you are uncertain about something or curious about it, speak up and ask. This is important for working in teams because it helps prevent small issues from becoming big problems. Good communication, whether with the customer or with colleagues, is essential for successfully completing a project and ensuring customer satisfaction.
