[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 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.
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
• 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
• 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 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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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
• 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
• 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 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/.
Apply Now
Apply Now