Principal Consultant, QA RA

Company Summary
Medicept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 28 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.
Please see medicept.com for more information.
Position Summary
The Principal Consultant, QARA is senior-level technical expert responsible for the integrity and successful delivery of complex Quality and Regulatory engagements. This role provides hands-on support for medical device projects while serving as a strategic technical liaison with clients. As a Technical Expert, the Principal identifies client pain points during project execution, suggests high-level strategies to address emerging needs, and advocates for additional Medicept solutions that provide immediate value. This hands-on role contributes to regulatory submissions, QMS development and remediation, audit readiness, compliance strategy, and integration of regulatory expectations into client operations. The ideal candidate brings strong FDA and international regulatory experience and thrives in a dynamic consulting environment.
Essential Duties and Responsibilities
Technical: Serve as a trusted advisor to clients, keeping a ‘pulse’ on their evolving needs and suggesting technical opportunities for expanded Medicept support based on expertise.
Problem Identification: Proactively identify client pain points related to QARA compliance during active projects and translate them into actionable business opportunities.
Solution Architecture: Architect high-level regulatory pathways and quality strategies – including 510(k), De Novo, and QMS remediation frameworks – to solve complex client challenges.
SOW Collaboration: Provide the initial technical framework for new projects and add-on services to ensure technical accuracy before contract finalization.
Regulatory Strategy: Determine device classification and complex regulatory pathways for US (EU/OUS market experience preferred but not required).
Technical Authority: Serve as the senior-most Subject Matter Expert (SME) for high-stakes regulatory submissions and quality remediations, including 483 responses and Warning Letters.
Audit Leadership: Lead and support internal, supplier, MDSAP, and ISO audits, as well as FDA inspection preparation.
QMS Remediation: Develop, maintain, and remediate QMS compliance with FDA QSR/QMSR, ISO 13485, and MDSAP requirements.
Deliver customized QMS and regulatory training programs for clients.
Conduct labeling, advertising, and promotional material reviews, including UDI compliance assessments.
Provide interim Regulatory/Quality leadership or adjunct quality staffing when needed.
General Consulting Responsibilities
Project Delivery: Manage multiple concurrent projects to successful, on-time, and on-budget completion.
Mentorship: Mentor junior and senior consulting staff, contributing to Medicept’s though leadership and overall service excellence.
Stakeholder Communication: Provide clear, proactive communication to clients, ensuring transparency and technical alignment throughout the project lifecycle, acting as a trusted advisor.
Participate in industry events and digital outreach to position Medicept as a leader in complex compliance and innovation.
Skills and Qualifications:
Bachelor’s degree in engineering, life sciences, regulatory affairs, or a related field.
12-15+ years of experience in medical device regulatory affairs, quality systems, or combination of both.
Expert knowledge of US FDA regulatory requirements; experience with other markets (EU MDR/IVDR, UK, Canada, Brazil, Japan, Australia, etc.) a plus.
Experience conducting or leading audits and supporting FDA inspections.
Hands-on experience with QMS implementation, maintenance, and remediation.
Strong project management, communication, and client-facing skills.
Experience with UDI implementation, including assigning and maintaining UDI data, supporting UDI requirements for labeling, packaging, and device marking.
Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and SharePoint.
Preferred
Certifications: RAC Certification and Lead Auditor certification.
Submission Track Record: Demonstrated experience preparing and defending complex regulatory submissions (e.g., multiple 510(k)s and developing regulatory strategies).At least one (1) 510(k)s and one (1) regulatory strategy in the past two years
Prior consulting and client relationship management experience are highly desirable.

Work arrangement
Yes