Principal Consultant - Regulatory Affairs

Avania is hiring for the position of Principal Consultant – EU / UK - Regulatory and Advisory Services .

We are seeking an experienced Principal Consultant with expertise in medical device regulatory strategy, especially with the U.S. FDA and EU MDR. This senior role requires strategic insight, hands-on regulatory experience, and the ability to guide medical device companies through complex regulatory environments.

As a Principal Consultant, you will lead advisory interactions with global clients entering the EU market, focusing on quality and regulatory compliance projects. You will drive consulting engagements, support revenue growth, and establish credibility with clients of various sizes, leveraging our clinical-to-commercial model.

Your responsibilities include understanding client needs, designing support programs, leading engagements, shaping regulatory strategies, negotiating with regulators, and guiding products throughout their lifecycle.

General Responsibilities

• Own the overall client strategy.
• Serve as a trusted advisor and strategist to solve critical business challenges.
• Synthesize client needs to produce comprehensive strategies.
• Articulate complex concepts clearly to cross-functional stakeholders.
• Lead and direct client projects ensuring strategic alignment.
• Act as a point of contact with regulatory authorities (e.g., FDA, Notified Body, TGA).

Project Management

Client Management

Business Development

The ideal candidate has 10+ years of senior regulatory affairs experience, with strong MDR / IVDR expertise, established Notified Body relationships, and either NB or consulting experience. A solid understanding of global regulatory requirements, including EU MDR, UK, Canada, and Australia, is essential. Experience in developing novel medical devices 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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