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:
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Contributing to regulatory strategies for EU MDR and other global markets
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Preparing and reviewing technical documentation
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Supporting market access activities and regulatory submissions
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Advising on regulatory requirements and classification
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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.
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:
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Technical or scientific degree (BSc, MSc, or PhD) in a relevant field (e.g. biomedical engineering, biology, chemistry, physics)
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3–5+ years of experience in Regulatory Affairs for medical devices
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Hands-on experience with EU MDR, regulatory submissions and technical documentation, and interactions with Notified Bodies or regulatory authorities
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Proven experience in writing and reviewing technical documentation, and supporting market access and regulatory strategy
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Ability to translate complex regulations into practical, business-oriented solutions
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Experience with quality management systems (ISO 13485) is an advantage, not a primary focus
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Audit experience (ISO 13485, MDSAP) is nice to have
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Strong communication and stakeholder management skills
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Ability to manage multiple projects in a dynamic, international environment
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Fluent in German and English
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Based in Germany
