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Medtronic · 2 days ago

Principal Software and Security Compliance Audit Specialist - Remote

United States

Full-time

Remote

Senior Level, Lead/Staff

$114K/yr - $170K/yr

5+ years exp

Medtronic is a global leader in healthcare technology, committed to championing healthcare access and equity. The Principal Software and Security Compliance Audit Specialist will lead audit activities focused on medical device software and product cybersecurity, ensuring compliance with regulatory standards and enhancing product security.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device

H1B Sponsor Likely

Responsibilities

Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements

Remain informed on Regulatory requirements for Software and Product Cybersecurity to identify gaps in medical device software

Manage and oversee internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents

Coordinate and/or complete internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities

Interpret and implement applicable regulations as they apply to products, processes, practices, and procedures

May counsel stakeholders about these requirements as necessary

Ensure compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns

Analyze audit data and present findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions

Own development of training and awareness programs for Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and product cybersecurity designed to increase auditor awareness and knowledge of requirements

Provide detailed functional medical device software and product security knowledge and maintain insight into current industry best practices and how they can be applied to Medtronic

Explore new tools and techniques to recommend for other team members to audit regulated medical device software and product cybersecurity

Identify opportunities for regulated medical device software and product security enhancement

Possess understanding of Software Bill of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring

Possess an understanding of non-probabilistic scoring methodologies for security threats like common vulnerability scoring system (CVSS) and apply appropriately

Document and communicate recommended state-of-the-art regulated medical device software and product cybersecurity controls and deficiencies

Contribute to company standards and policies related to regulated medical device software and product cybersecurity risks

Enable strong partnerships across the organization to drive best-in-class regulated medical device software and product cybersecurity development

Analyze complex issues and significantly improve, change, or adapt existing methods

Show creativity and innovation in all aspects of your responsibilities

Qualification

Medical device softwareProduct cybersecurityRegulatory complianceQuality Systems auditingSecurity certificationsRisk managementSoftware Bill of MaterialPenetration testingInterpersonal communicationCreative thinkingIndependent self-starterWriting skills

Required

Bachelor's degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+ years of work experience in Quality or regulated industry OR PhD with 3+ years of work experience in Quality or regulated industry