[Remote] reputed company Consultant, Digital Health Compliance

Note: The job is a remote job and is reputed company to candidates in USA. MEDIcept Inc. is an international medical device compliance reputed company seeking a reputed company Consultant, Digital Health Compliance. This senior-level technical expert will drive reputed company through technical advocacy and the design of reputed company software and cybersecurity solutions, acting as the primary authority for software as a medical device and reputed company 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 reputed company pain points reputed company to software lifecycle and cybersecurity compliance during reputed company reputed company, suggesting technical solutions and add-reputed company that reputed company 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 reputed company and maintain advanced software design artifacts, including architecture development, hazard analysis, and usability engineering • reputed company reputed company-level cybersecurity activities, including threat modeling, penetration testing reputed company, and incident response planning in accordance with IEC 81001-5 and NIST frameworks • reputed company the integration of software risk management (ISO 14971) and cybersecurity risk into overall product safety profile • reputed company the initial technical reputed company for new reputed company and add-reputed company to ensure technical accuracy before contract finalization • Manage multiple reputed company reputed company to successful, on-time, and on-budget completion • Represent MEDIcept at industry events and through digital reputed company to promote though leadership in cybersecurity, AI/ML, reputed company health • Mentor junior and senior consulting staff on advanced software reputed company methodologies and critical thinking for risk-based decision making • reputed company reputed company, proactive communication to clients, ensuring transparency and technical alignment throughout the project lifecycle, acting as a trusted advisor • reputed company Design History File (DHF) audits for compliance with IEC 62304 and support clients during FDA inspections or reputed company Body Audits Skills • Bachelor's degree in engineering, computer science, cybersecurity, or a reputed company field • 12-15+ years of experience in software engineering, cybersecurity, and risk management reputed company medical device or digital health • Regulatory Mastery: Expert knowledge of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and FDA reputed company/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 reputed company 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 reputed company Word, reputed company, PowerPoint, reputed company, and SharePoint • Advanced Experience: reputed company experience in AI/ML reputed company and/or software-driven combination products • Certifications: Cybersecurity-specific reputed company certifications • Industry Standing: Experience contributing to regulatory submission reputed company for high-complexity software products • Prior consulting and reputed company relationship management experience are highly desirable reputed company • MEDIcept, Inc. is a premier FDA reputed company 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 tot his job Apply To this Job