[Remote] Principal Consultant, Digital Health Compliance

Note: The job is a remote job and is open to candidates in USA. MEDIcept Inc. is an international medical device compliance consulting firm seeking a Principal Consultant, Digital Health Compliance. This senior-level technical expert will drive revenue through technical advocacy and the design of complex software and cybersecurity solutions, acting as the primary authority for software as a medical device and related engagements.

Responsibilities

• 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
• Proactively identify client pain points related to software lifecycle and cybersecurity compliance during active projects, suggesting technical solutions and add-on services that provide immediate value
• Architect high-level software development lifecycle (SDLC) strategies, including cybersecurity threat modeling, AI/ML robustness frameworks, and interoperability protocols
• Serve as the senior-most Subject Matter Expert (SME) for high-stakes software regulatory submission and cybersecurity risk management files, including SBOM remediation and vulnerability disclosure plans
• Work with clients to develop and maintain advanced software design artifacts, including architecture development, hazard analysis, and usability engineering
• Lead enterprise-level cybersecurity activities, including threat modeling, penetration testing oversight, and incident response planning in accordance with IEC 81001-5 and NIST frameworks
• Direct the integration of software risk management (ISO 14971) and cybersecurity risk into overall product safety profile
• Provide the initial technical framework for new projects and add-on services to ensure technical accuracy before contract finalization
• Manage multiple concurrent projects to successful, on-time, and on-budget completion
• Represent MEDIcept at industry events and through digital outreach to promote though leadership in cybersecurity, AI/ML, and digital health
• Mentor junior and senior consulting staff on advanced software quality methodologies and critical thinking for risk-based decision making
• Provide clear, proactive communication to clients, ensuring transparency and technical alignment throughout the project lifecycle, acting as a trusted advisor
• Lead Design History File (DHF) audits for compliance with IEC 62304 and support clients during FDA inspections or Notified Body Audits

Skills

• Bachelor's degree in engineering, computer science, cybersecurity, or a related field
• 12-15+ years of experience in software engineering, cybersecurity, and risk management within medical device or digital health
• Regulatory Mastery: Expert knowledge of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and FDA pre/post-market cybersecurity guidance
• Technical Depth: Deep understanding of software-based risk management, IoT ecosystem, secure connectivity, and SBOM requirements
• Proven ability to drive value revenue by identifying technical gaps and architecting solutions for clients
• Communication: Exceptional formal presentation and technical writing skills, with ability to influence audiences ranging from Engineers to C-Suite executives
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and SharePoint
• Advanced Experience: Direct experience in AI/ML security and/or software-driven combination products
• Certifications: Cybersecurity-specific professional certifications
• Industry Standing: Experience contributing to regulatory submission success for high-complexity software products
• Prior consulting and client relationship management experience are highly desirable

Company Overview

• MEDIcept, Inc. is a premier FDA consulting firm and full-service CRO specializing in medical devices, digital health, SaMD, combination products. It was founded in 1996, and is headquartered in Boston, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://www.medicept.com/.

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