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Consultant Medical Devices Quality & Regulatory Affairs

  • Hybrid
    • Stuttgart, Baden-Württemberg, Germany
    • Dortmund, Nordrhein-Westfalen, Germany
    • Düsseldorf, Nordrhein-Westfalen, Germany
    • Essen, Nordrhein-Westfalen, Germany
    • Karlsruhe, Baden-Württemberg, Germany
    • Köln, Nordrhein-Westfalen, Germany
    +5 more
  • Medical Devices

Job description

We have an exciting opportunity to join our team as Consultant Medical Devices Quality & Regulatory Affairs. In this role, you will serve a wide variety of clients in the medical device industry. With your medical devices regulatory knowledge, you are responsible for supporting Qserve clients to facilitate their business goals, assuring regulatory compliance and getting market access for a wide range of medical devices. You will be part of our international team of medical device experts, working from across the world.

Job requirements

What you’ll bring to the team

The candidate we are looking for is a passionate regulatory professional, who has experience in writing and reviewing medical devices technical documentation. With your understanding of the design and development process (specifications, verification, and validation) and risk analysis, you are able to engage a large variety of medical device technologies and guide clients to successful global compliance.

Your profile:

·        Technical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, physics, (medical) biology, or similar;

·        At least a few years of working experience in the field of medical devices (EU-MDD and EU-MDR) by fulfilling positions in the medical devices industry, another consultancy, or at a Notified Body, in either quality, regulatory or clinical roles;

·        Knowledge and/or understanding of quality assurance and regulatory affairs in the MedTech industry or Notified Body environment;

·        Knowledge of EU and US Medical Device Regulations;

·        Experience with writing technical documentation and regulatory documents;

·        Familiar with medical devices risk management;

·        Pragmatic, communicative, service-oriented and strong organizational skills;

·        Practical experience project management experience;

·        Fluent German and English;

·        Drivers license.

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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.