Qserve Group

Consultant

• 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.

Principal Consultant – US Market Expert