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

Entourage; Köln; Hybrid; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

An innovative firm is seeking a Senior or Principal Consultant to shape regulatory strategies in the IVD industry. This role involves leading consulting projects, developing solutions for regulatory challenges, and mentoring junior consultants. With a focus on EU IVDR and FDA regulations, you'll engage with senior stakeholders and manage cross-functional teams. The position offers a dynamic work environment with opportunities for professional growth and representation at industry events. If you have a strong background in regulatory affairs and a passion for consulting, this is the perfect opportunity to make a significant impact.

Leistungen

Open corporate structure

Continuous development opportunities

Networking at IVD events

Equal communication

Flexible salary structure

Qualifikationen

• Over 8 years of experience in RA and QA in the IVD industry.
• Deep knowledge of EU IVDR and FDA regulations.

Aufgaben

• Lead strategic consulting projects focusing on regulatory roadmap development.
• Develop tailored solutions for complex regulatory challenges.

Kenntnisse

Regulatory Affairs

Quality Management Systems

Clinical Evidence

Strategic Consulting

EU IVDR

FDA Regulations

Project Management

Mentoring

C1 Level German

C1 Level English

Ausbildung

Degree in Natural Sciences

Jobbeschreibung

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