Melissa Smits

Melissa Smits

Regulatory Affairs Associate


Introduction:


Melissa started working for Qserve in 2019. She was eager to learn more about the world of medical devices and thanks to her strong administrative and service-oriented skills, since 2021 she supports the Global Registration Team. Her focus is on the UK Responsible Person Service but she is able to support in other countries as well.

She is responsible for the submission of documentation for the registration of medical device and IVD companies and their products for worldwide market access. Melissa maintains contact with the clients and collects the relevant documentation to build registration files for clients. She reviews the submission documentation to check if these are complete and acceptable, and ensures that the devices and submission documentation is registered in the respective database (e.g. MHRA database for UK).

Melissa is most experienced in the legislation and database for the UK but also works for other countries’ databases for medical devices and in vitro diagnostics.

Before Qserve:

In a completely different field, Melissa started working as a dance teacher. Due to her background of learning and sharing expertise to other people, she is creative, enthusiastic and knows how to motivate people. After that, she worked as a Visual Merchandiser for an international brand. Working there for many years, she developed her managing skills and her eye for detail. Melissa believes in teamwork, has people skills and is good at multitasking.

Then she decided to take on a new challenge and she got the opportunity to start a position at Qserve. She uses her sense of empathy and knowledge of people to be of service to her clients, partners, health authorities, and colleagues to help keep things staying up and running.

Now, as a Regulatory Affairs Associate in the Global Registration team, she is responsible for submitting documentation for the registration of medical device and IVD manufacturers and their products in various countries.

Melissa about working at Qserve:

When I started at Qserve, I quickly felt like a part of the team. Rather soon, I got the opportunity to extend my function in the Global Registration team, where I am having contact with clients, partners and health authorities, and I took it with both hands. I like working in our team, keeping structure in our day-to-day work and helping out customers with a successful registration.

The key expertise areas of Melissa:

  • Support in Global registrations in various countries
  • Communication about registration requirements for market access, with a focus on the UK
  • Review and submit documentation for the registration of medical device and IVD manufacturers
  • Fulfill the registration process for customers by communicating with local competent authorities
  • Maintaining the UK Responsible Service within Qserve

Learn more about Regulatory Affairs

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