- Define the Product Cybersecurity Maturity Assessment in collaboration with IT and division cybersecurity leaders and subject matter experts based on a or multiple selected industry standard(s)/framework(s).
- Develop a software interface/data capture for the administration of the assessments utilizing an appropriate platform.
- Facilitate the completion of the maturity assessments in collaboration with IT and division cybersecurity leaders.
- Capture results and develop/distribute appropriate reports for all levels of the organization including executive/c-suite.
- Capture and provide input to remediation in collaboration with various areas such as control monitoring.
- Develop and complete a project charter for the remediation of product cybersecurity tools and systems to ensure compliance with quality system requirements.
- Partner with the Company's Quality and Regulatory and other functions, as appropriate, to ensure Product Cybersecurity policy is maintained.
- Support other product cybersecurity leaders, as appropriate, to advise, review, and solidify processes and procedures to meet security and quality system requirements.
- Automate manual tasks, time permitting.
- .6+ years of Medical Device industry work experience in cybersecurity, information security or related role or equivalent skill/experience.
- Expertise in maturity assessment frameworks, Medical Device FDA guidance, related global regulation and industry standards including: NIST, FDA Pre and post market guidance, ISO, IMDRF.
- Broader expertise in [Global] Quality System regulation desired (e.g., 21 CFR Part 807, 814, 820, 11).
- Ability to manage, administer, and support maturity assessment completion, capture results, remediation, and reporting.
- Advanced technical skill in Microsoft products, such as Forms and Excel or advanced programming skills in Python or other languages or the ability to quickly learn appropriate technologies.
- Ability to design and develop reports utilizing a tool like Power BI.
- BA/BS degree in MIS, Computer Science, Cybersecurity, Information Assurance, or related field.
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Product Cybersecurity Analyst - Saint Paul, United States - SMS Staffing Inc.
