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

About the company and your impact at EntourageDo 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 roleRegulatory 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 haveA degree in natural sciences or a comparable field of studyDeep knowledge and strong interest in strategic regulatory affairs and QMS topics, especially in a global and evolving IVD environmentMore than 8 years of hands-on experience in RA and/or QA in the IVD industry, consulting, or Notified Body sectorProven experience in strategic work: RA strategy development, regulatory due diligence, IVDR transition, FDA submissions, or similarSolid understanding of the EU IVDR and FDA regulations, international registration pathways is a plusExperience with in-house IVDs/LDTs topics is a strong advantageConfident and engaging communication style; ability to consult and influence at senior levelC1 level German and EnglishWillingness to travel (20-30% max.)What we bring to the tableAn open corporate structure and equal communicationAn exciting environment and continuous developmentThe 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?Wellpass membership, JobRad, corporate benefitsOpen salary structure depending on professional experience and education