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Consultant Medical Devices Regulatory / US submission expert

United States, Minnesota, MinneapolisMedical Devices

Job description

What you'll do

Currently, Qserve has an exciting opportunity to join our team as a Consultant Regulatory US. As a Qserve consultant, 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 and seeking FDA approval and US market access for a wide range of medical devices. You will be part of a team of medical device experts, working from across the world, dedicated to supporting our clients.

Job requirements

What you’ll bring to the team

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 an in-depth understanding of US regulations and are able to engage a large variety of medical device technologies and help clients to achieve FDA approval. In this role, you thrive on variety and be able to manage multiple projects. We are a service-oriented organization so you must thrive on helping others. You like to write technical documentation and regulatory documents.


Your profile:

  • Technical or scientific degree (BSc, MSc, or Ph.D.) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology, or similar;
  • At least 4 years of working experience in the Regulatory of medical devices;
  • Knowledge of US Medical Device Regulations;
  • Knowledge of other medical device regulations is preferred (EU MDR, PAL, TGA, etc.);
  • Direct 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 and driver's license.


Interested?

Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!


* This function will be executed remotely most of the time. We are open to candidates from all over the US.

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How we hire

Everything you need to know about your application process at Qserve Group

Getting to know you

In the first call, let our recruiter learn about you and your story to check a potential fit for Qserve. This is also a chance for you to ask first questions about the role and company.

Interview

In this meeting, your future manager takes a deeper dive into your experience and what you could bring to the team. Expect questions on how knowledgeable you are in your area of expertise.

Final chat

You made it to the very last stage! Here we have a final call to ask some additional questions. This meeting will be between you, your future manager and a team member.

Mutual interest

Is there a match? Then we will gladly make you an offer consisting of a suitable salary and our employment conditions. Do you accept our offer? Your adventure at Qserve Group will start!