Principal Consultant - Regulatory Affairs

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;

General 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:

• Demonstrated leadership managing medical device projects and teams.
• Ability to determine resourcing needs.
• Ability to independently analyze and provide project forecasts.

Client Management:

• Manage client accounts and maintain strategic, long-term relationships with
• key client decision-makers.
• Ability to interact with Senior level client personnel, Board of Directors, and Investors.
• Ensure client’s best interests are represented at all times, balancing client needs with Avania’s capabilities.
• Act as a bridge between the client’s executive team and the consulting team.
• Handle complex or high-risk issues that may arise within the project, stepping in when there are significant problems or disputes to resolve.

Business Development:

• Participate in new opportunity scoping calls, provide technical strategic input, craft proposals to support client needs, negotiate contracts.
• Generate new business by identifying opportunities within existing accounts, proposing new services or solutions, and negotiating contracts.
• Represent Avania in thought leadership activities, such as speaking at conferences or publishing articles, which can enhance Avania’s reputation and brand

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 -

• The opportunity to work in an innovative, fast-growing and rewarding industry
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Competitive compensation and benefits package (details shared during the interview process)
• Some roles offer the opportunities for travel
• Ask us about our hybrid and fully remote work opportunities

We look forward to receiving your application!

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