Regulatory Affairs Associate
Arnhem, Gelderland, NetherlandsGlobal Registrations
Qserve is a global consulting company and Clinical Research Organization (CRO), focusing on the Medical Device and In-Vitro Diagnostics industry. We help manufacturers worldwide with gaining market access, medical device registrations & approvals, in-country representation, achieving & maintaining regulatory compliance and clinical trials. With app. 100 colleagues worldwide, more than 20 nationalities and a great mix between junior and senior professionals, we provide our people with a highly diverse and dynamic working environment. Qserve is structured in a matrix with globally oriented business units and legal entities in different countries (The Netherlands, United States, Germany, Belgium, France, United Kingdom, Italy, and China), supported by our Global Support organization. We are rapidly growing and we have ambitious plans for the future. We are currently searching for a Regulatory Affairs Associate for our Global Registrations Business Unit, who is willing to contribute to that growth journey.
What you’ll do
In this role, you are responsible for supporting our clients with the registration of their Medical Device or In-Vitro Diagnostics (IVD) products, and with that, help them to gain market access. You collect all documentation from our customers, that is needed to build the registration files. You will review the documents for compliance and where needed update the documents. You structure and assess the received documents before submitting them in the relevant country database, as well as keeping our registration planning up to date. During the registration process, you closely cooperate with customers, colleagues, and health authorities from all over the world and you keep them informed about what is expected from them, and about the status of the registration. You stay up to date on (changes in) the regulations that apply to Medical Devices and In-Vitro Diagnostics in the various markets worldwide. You will be part of the Global Registrations team and report to the Head of the Business Unit Global Registrations.
What you’ll bring to the team
- Bachelor's degree;
- A few years of experience in a (project and/or sales) administrative role;
- Prior experience in a regulatory department and/or regulatory affairs is a big plus;
- Affinity with the MedTech industry;
- Excellent communication skills, both written and verbally, to interact with different customers from small to large multinationals;
- Service-oriented, structured and accurate working style;
- Ability to work independently and collaboratively in a rapidly growing, international working environment;
- Fluent in English, Dutch is a plus;
- Availability for at least 32h per week – position is head office based in Arnhem.
Getting excited about a career in a rapidly growing, dynamic, international working environment? Then please submit your CV and motivation!
How we hire
We have a thorough and flexible hiring process, to ensure we make the right decision and to help you to decide if we're the right fit for you.
First of all, thank you for your interest in a career at Qserve. All applications are reviewed by our HR department in close cooperation with the respective hiring manager. If we see a potential match, you will be invited for a first interview.
At this stage, we would like to take a deeper dive into your experience and what you could bring to the team. Besides that, we would love to tell you more about our company and people. You can expect several interviews with different relevant stakeholders.
Are you ready to sign your contract? Our HR colleague is looking forward to informing you about the employment conditions at Qserve, both primary and secondary. Your adventure at Qserve Group officially starts here!
We know how important it is to provide new hires with an engaging onboarding and warm welcome. As part of the structured program, you will be introduced to representatives of all our global teams and departments.