Consultant Regulatory Affairs (Senior o. Principal) In Vitro Diagnostic (m / f / x)

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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