3 of 3 ISO 13485 Jobs in Midlothian

security activities including Product Defense in Depth, security technology, regulatory compliance and incident response Domain specific standards and approaches on privacy and product security (ISO 2700x, NIST 800 Series Special Publications) Knowledgeable and experience with laws and regulations on cyber security, privacy, data protection and breach notification (e.g. … cyber security guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971. ISO 27001/27017/27018, ISO 30111; AAMI TIR 57; 21CFR820, SB1386, etc.) Experience in designing or leading software products using Secure SDLC Thorough Understanding of securing and hardening Windows ...

/GCP) Proven track record managing product security in a regulated healthcare or medical device setting Regulatory landscape such as FDA guidance, HIPAA, GDPR, ISO 13485, ISO 14971, AAMI TIR 57, ISO 27001 series, and 21 CFR 820 among others Technical credibility across cloud architecture, network ...

regulatory standards. Develop detailed project plans, requirements, specifications, schedules, and risk analyses. Negotiate trade-offs between schedule, resources, and product features. Ensure adherence to ISO13485, FDA CFR 820:30, and IEC 62304 standards. Provide regular updates and formal reviews to senior management and stakeholders. Manage contract resources and ensure quality ...