Key Qualifications
• Medical Device Experience (5+ Years):
• A minimum 5 years of direct, hands-on experience in medical device cybersecurity, preferably a Class III devices.
• Have demonstrated experience in creating documentation for at last one FDA 510K, PMA submission, or EU MDR technical documentation submission.
• Hands-on experience with standards like ISO 14971, IEC 62304 and ISO 13485 and experience in aligning these with regulatory requirements.
• Proven track record of working on devices with Bluetooth communication, mobile apps, and cloud integration.
• Regulatory Documentation Expertise:
• In-depth knowledge of FDA submission requirements, including:
• Cybersecurity documentation for 510(k) and PMA submissions.
• Creation of threat models, risk management files, and security testing reports tailored to FDA guidance.
• Familiarity with CE marking requirements for the EU, including:
• Cybersecurity sections for Technical Documentation under MDR.
• Ensuring compliance with ISO 14971, IEC 62304, and IEC/TR 60601-4-5.
• Demonstrated ability to produce submission-ready documentation in formats acceptable to both the FDA and Notified Bodies.
• SDLC Integration:
• Expertise in integrating threat and vulnerability management across the Software Development Lifecycle (SDLC).
• Ability to trace threats, risks, and mitigations through design, development, and testing stages, ensuring that all necessary artifacts are prepared and submission-ready for the specific Notified Body.
• Cybersecurity Risk Management:
• Experience in conducting and documenting:
• Threat modeling (e.g., STRIDE).
• Risk assessments and alignments with AAMI TIR57 and ISO 14971.
• Security testing results, including penetration testing and vulnerability assessments, documented in submission-ready formats.
• Standards and Compliance:
• Familiarity with relevant standards for medical device cybersecurity:
• FDA Premarket Guidance for cybersecurity risk management.
• ISO 13485 for quality system integration.
• IEC 62304 for secure software lifecycle processes.
• Communication and Collaboration:
• Strong ability to work cross-functionally with engineering, regulatory, and quality teams to ensure submission documentation meets all regulatory requirements.
• Experience presenting and defending cybersecurity strategies and documentation during audits or regulatory reviews.
Additional Information
:No of position – 1 (50% capacity which is 86 hours a month
)Duration – 5 to 6 months (Aug – Dec 2026) with possibility to extend furthe
rWork location: Remote (may have to occasionally travel to Houston customer office for meetings/workshops
)
Location: , ,
LinkedIn: Apply Here