Qserve Group

Principal Consultant – US Market Expert

Qserve Group

full-time

Posted on:

Location Type: Remote

Location: District of Columbia • Maryland • United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Lead

About the role

  • 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.

Requirements

  • 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.
Benefits
  • Medical Devices 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategiespathway assessment510(k)De NovoPMAIDEregulatory submissionsclinical strategy integrationlifecycle regulatory planningbriefing packages
Soft Skills
relationship buildingstrategic discussionstrusted advisorcommercial mindsetengaging stakeholderscommunication skillsconsulting skillsnetworkingindependent workcollaboration
Certifications
Bachelor’s degree in EngineeringBachelor’s degree in Life SciencesBachelor’s degree in Regulatory Affairs