Note: The job is a remote job and is open to candidates in USA. Medicept is an international medical device, IVD, combination product, and biotechnology compliance consulting firm providing regulatory, quality, and clinical services. The Principal Consultant, QARA serves as a senior technical expert leading complex quality and regulatory engagements, including regulatory submissions, QMS development and remediation, audit readiness, compliance strategy, and client advisory support.
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
- • 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
- • 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
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