Principal Consultant

Overview

Avania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that fosters growth, innovation, and collaboration.

Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.

Avania are Hiring – Principal Consultant – EU / UK - Regulatory and Advisory Services

Avania is adding to our dynamic, multi-disciplinary Regulatory and Advisory Services team. We are seeking an experienced Principal Consultant with deep expertise in medical device regulatory strategy, particularly with the U.S. FDA and EU MDR. This is a senior-level technical role for a regulatory expert who brings strategic insight, hands-on regulatory experience, and a proven ability to guide medical device companies through complex regulatory landscapes.

In the role of Principal Consultant, you will lead advisory interactions with global clients entering the EU market for both quality as a service and regulatory compliance advisory projects, driving consulting engagements and supporting our Advisory Services revenue growth targets. This role will need to immediately establish credibility with small, mid-sized, and large medtech clients and leverage our integrated clinical-to-commercial model.

The Principal consultant role will engage with potential new clients to understand their products and needs, design client support programs, lead client engagements, shape regulatory strategies for novel technologies, negotiate with regulators such as FDA, and provide expert guidance throughout the product lifecycle—from development through submission and post-market activities.

The role of Principal Consultant will involve the following;

Responsibilities

• Own the overall client strategy.
• Service as trusted advisor and strategist, helping clients solve their most critical business challenges.
• Strong ability to synthesize all details, including client business needs, to produce a comprehensive strategy.
• Ability to articulate complex concepts in a simple way which can be understood by cross-functional stakeholders.
• Lead and direct client projects, ensuring strategic alignment and successful delivery.
• Act as point of contact with regulatory authorities (e.g. FDA, Notified Body, TGA etc) as needed for the client.

Project Management

Client Management

Business Development

Qualifications

The ideal candidate will have 10+ years of senior regulatory affairs experience, particularly strong MDR / IVDR implementation expertise and established Notified Body relationships, with NB and / or consulting experience preferred, combined with a strong understanding of regulatory requirements across multiple global markets, including the EU MDR, UK, Canada, and Australia. Experience working as a regulatory consultant or within a company developing a novel medical device is highly desirable.

We offer

We look forward to receiving your application

When you need to advance your career, it takes Avania

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