Welcome Vanessa Caldeira - Medical Device QA/RA Consultant

Hello and a warm welcome to PhamaRelations! How are you feeling?

Thank you, I could not have asked for a warmer welcome. I have felt as part of the team from day one 😊 As to how I am feeling, in one word: EXCITED! I am extremely happy to join the team and very excited about what lies ahead.

What motivated you to join us at PharmaRelations?

The main motivator was working with Emma Axelsson again; we work great together which is important to me. That, and the possibility to help her build a Medical Device brand within PharmaRelations; there is something very alluring about building something from scratch.

The company's culture also truly resonated with me in the way it fosters collaboration and a commitment to progress. Being part of an environment that values continuous learning and encourages pushing boundaries inspires me to contribute my best every day. I look forward to challenge myself and to continuously grow through actions, teamwork, and a bold, passionate approach.

Can you tell us a bit about your previous experience?

I’m originally from Brazil but my academic journey took me across the world. I earned my undergraduate degree in Biology and a master’s in Life Sciences in Japan, conducted neuroscience research at the Max Planck Institute in Germany, and completed a Ph.D. in neuroscience at the Karolinska Institute in Sweden.

For over 8+ years, I have worked in regulatory affairs and quality assurance for medical devices within the MedTech and Pharmaceutical industries both in Sweden and Denmark, striving to bring medical innovations to patients. My expertise also extends to connected medical devices, including both end-to-end and interoperable solutions. I have been actively involved in every stage of the value chain, from development and production to post-market activities.

I started my journey at Bactiguard AB where I worked as a technical project manager for a Class III product and an R&D project lead for technology out-licensing. I then moved on to a new chapter as the Quality and Regulatory Manager at NuvoAir AB, a respiratory digital health start up at the time. As one does at startups, I wore many hats and worked with Quality Management and Regulatory Strategy. It was then that I took a deep dive into the world of software as a medical device, AI, interoperable solutions and cybersecurity. I then entered the pharma world by joining Lundbeck A/S and continued my commitment to digital health as a Senior Regulatory Specialist within digital health. I had the chance to develop a new skillset, and lead projects and initiatives in regulatory digital health and medical devices, focusing on integrating digital endpoints and devices into drug development. My last stop before joining PharmaRelations was at the pharma giant Novo Nordisk A/S where I worked as a Global Regulatory Lead within Digital Health and developed and implemented global regulatory strategies from product concept to market launch.

My diverse experience across different countries and regulatory landscapes has shaped my ability to navigate complex challenges and drive meaningful impact in the field and across the medical device value chain.

What excites you most about your new role?

Problem-solving, or better yet, solution-finding. This is my first experience as a consultant, and I’m eager to work on a diverse range of projects.

The opportunity to support multiple companies on their journeys is especially exciting and makes the work feel truly meaningful.

What are you most passionate about in your work?

I am a strong believer in science and innovation and am passionate about bringing life-changing and life-saving innovations to the hands of patients.

My mission is to support companies driving innovation within medical devices and digital health to navigate their path to success in a compliant, cost-effective and agile manner.

In my view, their success translates to better care for those who need it the most; there is no better driver than this.

What do you enjoy doing in your free time?

I am a mother of two toddlers so any free time I do have is taken up by playlands, museums, playdates and a lot of fun with the little ones. But I do try and fit in a glass of wine with friends, any type of pilates and, whenever possible, some travelling. As a globe trotter, travelling is something I cannot do without 😉

A warm welcome to PharmaRelations Vanessa!