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
Demonstrate leadership in managing medical device projects and teams. Determine resourcing needs. Analyze and forecast project outcomes independently. Client Management
Manage client accounts and maintain long-term relationships with key decision-makers. Interact with senior client personnel, Boards, and Investors. Represent client interests, balancing needs with company capabilities. Bridge between client executives and consulting teams. Handle complex or high-risk issues proactively. Business Development
Participate in opportunity scoping, proposal crafting, and contract negotiations. Identify new business opportunities within existing accounts. Engage in thought leadership activities like speaking and publishing. 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: The chance to work in an innovative, fast-growing industry. A collaborative, global team environment. Opportunities for knowledge exchange, growth, and career advancement. Competitive compensation and benefits (details shared during interviews). Travel opportunities for some roles. Hybrid and fully remote work options available. We look forward to receiving your application! When you need to advance your career, it takes Avania! LI-DNI
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