We would like to get you all acquainted with our US Regulatory Affairs Expert. An interview where we talk about her expertise, how a normal workday looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
Let's start with a small introduction, could you tell me something about yourself?
I’m a writer at heart with a scientific-leaning brain; I like to use both my technical knowledge and my writing skills equally, which is why I feel so at home in the Regulatory world.
What is your main area of expertise?
My expertise is primarily in medical devices (MDs), in Regulatory. I have worked in Quality Control, Diagnostics, Biologics, as well as the Medical Device world.
Could you also tell me something about your experience before you joined Qserve?
I spent 4 years in quality control for biological products and Diagnostics before transitioning into Regulatory for medical devices for the next 4. My primary focus in Regulatory was always OUS Regulations, specifically Europe but also ROW (Rest of World), such as Latin America, non-EU Europe, Middle East and Africa.
Which part of your job do you like the most?
I love working in the development of regulatory strategy for companies, especially small to mid-size, considering all aspects of their product development process. However, no two days are alike, which is an aspect I especially enjoy; the scope of the work and projects extends across every size manufacturer and every type of product. Additionally, I am always humbled by the extensive breadth of knowledge of my team members, and the incredible culture of support and knowledge-sharing that we employ. I also enjoy interfacing with a variety of clients and questions – it is truly empowering to be able to help them bring compliant devices to market and build trusting relationships across the board.
How does a normal workday look like?
My day always begins with many cups of coffee! COVID has not changed the structure of my workday as much, since in the US we are remote based. However, I do miss the face-to-face interactions with clients and team members; being able to sit down together to accomplish a goal is something I never took for granted, especially because I did not work in that type of environment every day!
Usually, mornings are for ‘’heavy lifting’’ work unless client emergencies come up – technical writing, submissions, client meetings and Q&A, deep work. If I need to interact with Europe and China, that is the time of day to do it. I try to schedule internal meetings and strategic planning sessions in the afternoon, when I also catch up on a majority of e-mails, blogs, question threads, while checking up on any Regulatory news or topics that I need to be aware of.
Do you prefer a specific type of medical device?
I like working with combination drug/device or device/drug devices, as well as devices incorporating specific components such as animal tissue. I enjoy the added layer of regulatory complexity to these Class III devices, which incorporates technical knowledge from the pharma/biologics, cosmetic, or diagnostics industries.
Which trends do you observe at the moment?
MDR and more MDR! Even with the postponement until 2021 due to coronavirus, while the extra breathing room is helpful, the extensive additional requirements for compliance from the MDD to MDR, it is imperative that manufacturers stay on track with all the various efforts required.
How do you stay up to date with everything that is happening in the MedTech-world?
At Qserve, we gather information from our various networks and areas of expertise and share them with the larger team – this is one of the benefits of working within a consultancy that has such varied expertise.
What is your advice/message for our customers?
Regardless of your size as a manufacturer, don’t delay preparing for the MDR; it will still be here before you realize it! Follow us at Qserve for our latest blogs, trainings, webinars and let us know how we can help you accomplish your compliance goals in 2020 and the coming years. We are a tightly-knit team and provide a customized approach to tackling all of your needs, integrating everything from clinical research, marketing, worldwide regulatory and manufacturing requirements.
Would you like to know more about Adriana? Click here for her full profile.