About the company and your impact at Entourage
Do you want to shape regulatory strategies and support the transformation of the IVD industry ? At Entourage, we partner with leading diagnostics companies to drive innovation, compliance, and growth.
Our IVD consulting team is looking for a Senior or Principal Consultant (m / f / x) in Munich / Remote, starting as soon as possible, to strengthen our strategic expertise in Regulatory Affairs, Quality Management, and Clinical Evidence .
About the role
* Regulatory Strategy & Consulting : You will lead strategic consulting projects with our clients, e.g. focusing on regulatory roadmap development, global registration strategies, gap assessments, and decision-making support for senior stakeholders. Your work will cover EU IVDR, FDA, and other key markets, including interaction with Notified Bodies and Competent Authorities.
* Analysis & Solution Development : You will develop tailored, forward-looking solutions for complex regulatory and quality-related challenges—ranging from performance evaluation planning to regulatory market access strategies.
* Execution & Leadership : You will manage projects and cross-functional teams, ensure timely and compliant implementation of regulatory or QA / clinical work packages, and act as a trusted advisor to our clients. As a senior expert, you’ll also mentor junior consultants and contribute to the continuous development of our consulting methodologies.
We are a match, if you have
* A degree in natural sciences or a comparable field of study
* Deep knowledge and strong interest in strategic regulatory affairs and QMS topics, especially in a global and evolving IVD environment
* More than 8 years of hands-on experience in RA and / or QA in the IVD industry, consulting, or Notified Body sector
* Proven experience in strategic work : RA strategy development, regulatory due diligence, IVDR transition, FDA submissions, or similar
* Solid understanding of the EU IVDR and FDA regulations, international registration pathways is a plus
* Experience with in-house IVDs / LDTs topics is a strong advantage
* Confident and engaging communication style ; ability to consult and influence at senior level
* C1 level German and English
* Willingness to travel (20-30% max.)
What we bring to the table
* An open corporate structure and equal communication
* An exciting environment and continuous development
* The chance to visit IVD events, networking in the IVD health world, while representing the Entourage at exhibitions, events, speaker events - or be the speaker yourself?
* Open salary structure depending on professional experience and education
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