At Qserve, we take pride in our team of experts who support global registrations for medical devices in various countries. Today, we are excited to introduce you to Melissa Smits, Project Manager and Senior Global Registration Specialist. In her role, she oversees the entire registration process and ensures accuracy of all submitted documents.
Melissa started working for Qserve in 2019 as an Executive Assistant & Office Manager. Rather soon, in 2021, she was given the opportunity to extend her function by joining the Global Registration Team. With her team she supports manufacturers with market access across various countries.
Her initial responsibility was to set up the UK Responsible Person service, now supporting over 300 customers. While Melissa has extensive experience with UK legislation, registration requirements, and regulatory database submissions, she also manages registrations in other countries for medical devices and in vitro diagnostics. In addition, she’s expanded her reach, managing and overseeing the US Agent, EU Authorized Representative, and China Agent services, ensuring regulatory compliance, seamless coordination with authorities, and consistent service delivery across multiple regions.
Currently, Melissa is a Project Manager & Senior Global Registration Specialist at Qserve. In this role, she leads and coordinates end-to-end registration projects, from planning timelines and gathering documentation to reviewing and submitting complete registration files. She acts as the primary point of contact with local health authorities and ensures that all submissions are accurate, complete, and compliant.
Melissa’s background has equipped her with strong project management skills, including prioritizing tasks, managing multiple registrations simultaneously, and keeping stakeholders aligned. Her attention to detail, combined with her communication skills and empathetic approach, allows her to keep projects running smoothly. In practice, this means maintaining close collaboration with clients, partners, and regulatory authorities, while efficiently organizing the documentation needed to build compliant registration files.
We support medical device and IVD manufacturers with reliable regulatory services across key global markets. From meeting legal requirements to acting as your local representative, we make compliance simple and help you access markets with confidence. Get in touch with us today to explore how we can support you!