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Consultant Medical Devices Regulatory Affairs

  • Hybrid
    • Dortmund, Nordrhein-Westfalen, Germany
    • Düsseldorf, Nordrhein-Westfalen, Germany
    • Karlsruhe, Baden-Württemberg, Germany
    • Essen, Nordrhein-Westfalen, Germany
    • Köln, Nordrhein-Westfalen, Germany
    • Mainz, Rheinland-Pfalz, Germany
    • Koblenz, Rheinland-Pfalz, Germany
    +6 more
  • Medical Devices

Regulatory Affairs consultant for medical devices, supporting EU MDR/global compliance, technical documentation, submissions, and market access for international clients in Germany.

Job description

What you’ll do

Qserve offers an exciting opportunity to join our team as a Consultant Medical Devices Regulatory Affairs. In this role, you will support clients in the medical device industry, with a strong focus on regulatory strategy, compliance, and market access. Leveraging your regulatory expertise, you will guide clients through complex global regulatory frameworks and help bring innovative medical devices to market efficiently and compliantly.

You work closely with clients on a variety of regulatory topics, for example:

  • Contributing to regulatory strategies for EU MDR and other global markets

  • Preparing and reviewing technical documentation

  • Supporting market access activities and regulatory submissions

  • Advising on regulatory requirements and classification

  • Keeping up with regulatory developments and helping clients apply them in practice

You’ll collaborate with colleagues and clients across different disciplines and countries, making sure projects move forward and regulatory requirements are met.

Job requirements

What you’ll bring to the team

We are looking for a Regulatory Affairs professional with experience in medical devices and a strong interest in compliance and market access. You enjoy working on a variety of regulatory topics and helping clients navigate requirements across different markets. You take ownership of your work and feel comfortable supporting and advising clients on regulatory matters.

Your profile:

  • Technical or scientific degree (BSc, MSc, or PhD) in a relevant field (e.g. biomedical engineering, biology, chemistry, physics)

  • 3–5+ years of experience in Regulatory Affairs for medical devices

  • Hands-on experience with EU MDR, regulatory submissions and technical documentation, and interactions with Notified Bodies or regulatory authorities

  • Proven experience in writing and reviewing technical documentation, and supporting market access and regulatory strategy

  • Ability to translate complex regulations into practical, business-oriented solutions

  • Experience with quality management systems (ISO 13485) is an advantage, not a primary focus

  • Audit experience (ISO 13485, MDSAP) is nice to have

  • Strong communication and stakeholder management skills

  • Ability to manage multiple projects in a dynamic, international environment

  • Fluent in German and English

  • Based in Germany

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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.