Updated: Jul 12, 2022
We’ve been doing a lot of tech team recruiting recently, but a groundbreaking technology platform won’t achieve breakthrough device designation from the FDA by itself… Enter regulatory guru Giovanni Maggi! Our new Quality & Regulatory Transformation Lead, who joined us last January.
Hi Gio! Tell us more about yourself.
I'm from Bari in the south of Italy (so a little bit warmer than here!). But I moved from Italy almost 12 years ago and I found my home here in the UK. After completing my MEng in Electronics and a PGDip in Biomedical Engineering, I worked for 8 years in the medical device sector. Previously, as Quality Manager for Vision RT, I had been responsible for managing the Quality Management System and Regulatory obligations throughout the full product lifecycle. There, I restructured the entire QMS while setting up a new manufacturing site. Recently, as Head of QARA (Quality Assurance & Regulatory Affairs) in an AI medical device start-up, I have achieved the first CE mark and first 13485:2016 certification while meeting tight deadlines.
I was only planning to stay a year after my studies, but I found a job and met my wife so I’m still here! – Maybe I’ll go back when I retire. My two little kids fill all my free time. Luckily the Cambridge area is ideal to find a lot of funny activities for them.
What does your role at BIOS involve?
In my role as Quality and Regulatory Transformation Lead, I'm the first employee fully dedicated to QARA, and this is very exciting as BIOS is approaching key milestones. I’m building our quality system ready for certification to get BIOS to the next level and supporting our new therapy area from a regulatory perspective.
What made you decide to become a BIOneer?
The platform that we are developing is what attracted me a lot. BIOS is developing a breakthrough medical device that will change the world of digital therapies in the neuromodulation sector. Coming from a medical device background, I like the combination of hardware and software and this product is a really exciting and challenging one for me.
What have you been up to in your first few months at BIOS? Our first Neural Digital Therapy application for heart disease (coming out of the BIOS platform) will go through the FDA Breakthrough Device pathway. So I have been doing lots of internal audits and setting up the Quality Management System to prepare BIOS to the first 13485 certification. This certification will enable us to deliver the first human clinical test with software that can read and write neural signals, so I'm really excited about it!
Then I supported the current projects with my experience in Quality and Regulatory. I love to be challenged and the platform that BIOS is developing is very complex and unique. I also love that I am able to use my experience and knowledge to help with trial strategy at board level. Whether you want to do trials in the US or in Europe, it all has regulatory implications to consider, and they differ by country. So it’s nice to feel I’m genuinely making a positive impact on our journey.
What is the interview process at BIOS like? The interview process is very nice and smooth. You can meet almost everyone in the company and this helps to understand the unique company culture. Speaking to the founders Oliver and Emil was really good because I got to understand a bit more about the platform and the technology behind it.
How would you describe the culture here? BIOS has a great work-life balance. We work on tight deadlines, but we have also a lot of social events and Team building events where we have a lot of fun! - At least once a month we go for a beer together.
What are the coolest perks about working at BIOS?
The free snack cupboard is nice, but flexibility and hybrid working is the most important for me as I have 2 little kids. Sometimes my wife isn’t able to pick up the kids at exactly 3pm, so I’ll pick them up from nursery (there is no flexibility with them). But then she comes home about 10 minutes later and looks after them while I continue to work from home.
What are you looking forward to in the next 1-2 years of your career here? I want to see BIOS develop and grow to the next level as it is in the plan, and to bring our unique neural digital therapy to the medical device market! Of course, to accomplish this we need to achieve 13485 certification first, and then ensure our system is maintained to keep that high standard!