[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, Outlook, 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/.
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