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Consultant Medical Devices Regulatory / US Submission Expert

Hybrid
  • Arnhem, Gelderland, Netherlands
  • Düsseldorf, Nordrhein-Westfalen, Germany
  • Essen, Baden-Württemberg, Germany
  • Liège, Région Wallonne, Belgium
  • Paris, Centre-Val de Loire, France
  • Stuttgart, Baden-Württemberg, Germany
+5 more
Medical Devices

Job description

What you'll do

Qserve has an exciting opportunity to join our team as a Consultant Medical Devices Regulatory / US Submission Expert. As a consultant at Qserve, you serve a wide variety of clients in the medical device industry. With your regulatory knowledge of medical devices, you will be responsible for helping Qserve clients with regulatory writing, achieving FDA approval and getting US market access for a wide range of medical device products. You will be part of a team of medical device experts, working from all over the world, dedicated to supporting our clients.


In this role, the candidate we are looking for is a highly motivated and passionate regulatory professional, who has experience in writing and reviewing US submission files of medical devices (510(k) and preferably PMA). You have a good understanding of US regulations and are able to engage a large variety of medical device technologies and help clients to achieve FDA approval. You are able to manage multiple projects and like to write technical documentation and regulatory documents.


Qserve has different legal entities across Europe. We are looking for a Consultant Medical Devices Regulatory / US Submission Expert for one of these legal entities (Netherlands, Germany, Belgium/France, UK). 

Job requirements

What you’ll bring to the team

  • Technical or scientific degree (BSc, MSc, or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology, or similar;
  • At least 2 - 5 years of working experience in regulatory and/or the medical devices field;
  • Knowledge of US medical device regulations;
  • Experience with writing technical documentation and regulatory documents for US submissions;
  • Experience with Medical Device Quality management systems 21CFR820/ ISO 13485;
  • Communicative and service-oriented;
  • Fluent in English;
  • Working permit.


Interested?

Getting excited about a career as a consultant in the dynamic and innovating world of medical devices? Then please submit!

or

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.

Screening

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.

Interview(s)

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.

Employment conditions

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!

Onboarding

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.