MEDIcept Inc. · 2 days ago
Principal Consultant, Digital Health Compliance
United States
Full-time
Remote
Lead/Staff
12+ years expMEDIcept Inc. is an international consulting firm specializing in medical device, IVD, and biotechnology compliance. The Principal Consultant, Digital Health Compliance is a senior-level technical expert responsible for driving revenue through technical advocacy and the design of complex software, cybersecurity, and risk management solutions.
Medical Device
No H1B
Hiring Manager
Nick Radoux
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
Qualification
Required
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
Expert knowledge of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and FDA pre/post-market cybersecurity guidance
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
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
Preferred
Direct experience in AI/ML security and/or software-driven combination products
Cybersecurity-specific professional certifications
Experience contributing to regulatory submission success for high-complexity software products
Prior consulting and client relationship management experience are highly desirable
Company
MEDIcept Inc.
MEDIcept, Inc. is a premier FDA consulting firm and full-service CRO specializing in medical devices, digital health, SaMD, combination products.
11-50 employees
Funding
Current Stage
Early StageRecent News
Med-Tech Innovation
2024-05-23
Company data provided by crunchbase