IT Security Expert

at  Seargin

EXPERIENCE LEVEL:

Senior

QUALIFICATION ACTIVITIES

Perform qualification activities for service provider’s digital compliance partners, including Contracted Research Organizations (CROs), Central Laboratories, and providers of digital healthcare solutions, digital biomarkers, medical devices, and software as medical devices (SaMD)
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HEALTH AUTHORITY GOVERNANCE KNOWLEDGE

Maintain expert-level knowledge of the dynamic health authority governance to ensure compliance and inform risk management strategies
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GLOBAL ENTERPRISE IT EXPERIENCE

Have 5+ years of experience in a large global enterprise IT environment within quality assurance for software development, preferably in the medical device industry
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EDUCATIONAL QUALIFICATIONS

Hold a BA or BS in informatics, life science, business, or equivalent; MA or MS and post-graduate coursework are desirable
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REGULATORY KNOWLEDGE

Possess practical knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, EMA Annex 11, EMA MDR, IVDR regulations, and ISO 13485 standard
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MEDICAL DEVICE QA EXPERIENCE

Have experience in quality assurance for software development as a medical device to ensure compliance and quality standards are met
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DRUG DEVELOPMENT PROCESS KNOWLEDGE

Have an understanding of the drug development process to integrate quality assurance practices within this context
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PROFESSIONAL AUDIT AND IT SECURITY EXPERIENCE

Possess professional experience in audits, risk management, IT security, or IT privacy to enhance quality assurance practices (desirable)
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COMMUNICATION SKILLS

Exhibit strong communication skills to convey complex information, issues, and potential solutions at an executive level
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