Principal Consultant US Market Expert

Principal Consultant US Market Expert Newark, NJ Job Details Full-time 21 hours ago Qualifications Revenue growth FDA submissions Business development within consulting Identifying new business opportunities Engineering Client services experience within consulting industry Bachelor's degree in engineering Bachelor's degree Customer relationship management Organizational skills Participating in conferences Regulatory submissions Senior level Leadership Communication skills Negotiation Stakeholder relationship building Consulting firm experience Stakeholder management 10 years Full Job Description 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.