Principal Consultant US Market Expert

What you’ll do As a U.S. Medical Device Regulatory Strategy Expert, you play a key role in expanding our presence in the U.S. MedTech market. You combine deep regulatory expertise with a strong commercial mindset, building and growing your own client portfolio while supporting medical device companies in achieving successful market access. Working within our global consulting team, you act as a trusted advisor to clients and as a visible representative of our organization in the U.S. market. Your responsibilities:

• Take ownership of developing and growing your client portfolio within the U.S. MedTech market, building long-term relationships with key industry players.
• Identify, develop, and convert new business opportunities, contributing directly to revenue growth and market expansion.
• Act as a senior point of contact for clients, leading strategic discussions and positioning our services at executive level.
• Develop regulatory strategies for U.S. market access, including pathway assessment (510(k), De Novo, PMA), pre-submission planning, clinical strategy integration, and lifecycle regulatory planning.
• Lead interactions with the FDA, including Pre-Subs (Q-Sub), IDE meetings, PMA panel meetings, and deficiency response negotiations.
• Prepare and review high-quality regulatory submissions, such as 510(k), De Novo, PMA, IDE, and supplemental submissions.
• Act as a trusted advisor to clients, translating complex regulatory requirements into clear, actionable business strategies.
• Represent the organization as a visible expert in the U.S. MedTech ecosystem, leveraging your network and actively contributing at conferences, industry events, and client engagements.
• Collaborate with global colleagues while operating with a high degree of autonomy in a commercial consulting environment.

What you’ll bring to the team We are looking for a commercially driven regulatory leader with a strong network and proven ability to build client relationships and drive business growth in the U.S. MedTech market. Your profile:

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
• 10+ years of experience in medical device regulatory affairs within industry, consulting, or a combination of both.
• Deep expertise in U.S. medical device regulations, including FDA pathways such as 510(k), De Novo, PMA, and IDE.
• Extensive experience interacting with the FDA, including preparation of briefing packages and leading regulatory meetings.
• Experience with international medical device regulations in addition to U.S. requirements is preferred.
• Proven ability to build, maintain, and expand a professional network within the U.S. medical device ecosystem.
• Demonstrated commercial mindset, with experience in identifying opportunities, developing client relationships, and contributing to business growth.
• Strong presence and credibility, with the ability to engage and influence senior stakeholders.
• Excellent communication and consulting skills, translating regulatory complexity into strategic and business-oriented advice.
• Experience working independently while collaborating within a global consulting team.
• Willingness to travel within the U.S. and globally to support client engagements, conferences, and business development activities.

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