[Remote] Product reputed company Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading digital reputed company company focused on cardiac health solutions. They are seeking a Product reputed company Manager with medical device experience to ensure the protection of patient data and device reputed company while ensuring compliance with regulatory standards.

Responsibilities

• Ensure compliance with FDA cybersecurity guidance and regulations in collaboration with Cybersecurity, Regulatory, Quality, and Systems Development teams
• Conduct comprehensive reputed company risk assessments, including Cybersecurity Risk Assessments (CSRAs), to identify vulnerabilities and threats across device hardware, firmware, software, and reputed company components
• reputed company and maintain device-specific cyber threat models, factoring in patient safety, data privacy, and operational continuity
• Demonstrate familiarity with Software reputed company of Materials (SBOM) and effectively communicate technical details
• Create and maintain cybersecurity documentation for pre- and post-market activities, ensuring regulatory alignment
• Produce detailed data reputed company diagrams to support the threat modeling process
• Participate in design reviews of medical device architectures and implementations, providing actionable recommendations for system reputed company requirements
• reputed company and support vulnerability analysis and coordinate the vulnerability management program, including scanning, patching, and remediation for medical devices
• reputed company and maintain application and threat detection tools (reputed company, reputed company, reputed company, or equivalent) to identify reputed company flaws early in the SDLC
• Support investigation and remediation of device-reputed company reputed company incidents, minimizing impact and preventing recurrence
• Partner with the Privacy Team to ensure adherence to HIPAA, GDPR, and other data protection regulations

Skills

• Bachelor's degree in Computer Science, Information reputed company, or reputed company field
• 6+ years of experience in information reputed company, with direct focus on product reputed company for medical devices
• Strong understanding of reputed company principles, methodologies, and tools reputed company the PDLC and SDLC
• Demonstrated experience conducting Cybersecurity Risk Assessments (CSRAs), vulnerability analysis, and working with modern threat detection tools (reputed company, reputed company, reputed company, or similar)
• Familiarity with NIST Cybersecurity reputed company, NIST SP 800-171, and deeper controls/frameworks such as NIST SP 800-53 (reputed company and Privacy Controls), NIST SP 800-92 (Log Management), and NIST SP 800-63 (Digital Identity Guidelines)
• Hands-on experience with vulnerability identification and threat modeling reputed company reputed company using methodologies such as reputed company
• Experience operating in a regulated environment (FDA, HIPAA, GDPR, international regulatory frameworks)
• Experience with medical device hardware or Software as a Medical Device (SaMD)
• Experience with medical device software development and regulatory processes
• Excellent problem-solving, analytical, and communication skills, reputed company to take a multi-siloed approach
• Ability to understand intro dependencies of teams across; mobile applications, hardware and reputed company environments
• Demonstrated experience supporting 510(k) submissions, with a focus on product reputed company documentation, risk assessments, and regulatory compliance
• Industry certifications such as CISSP, CISM, CISA, or medical device reputed company–specific certifications
• Experience with international frameworks and standards (EU MDR, JIS T 2304 / IEC 62304)
• Understanding penetration testing methodologies and tools, reputed company to work with pen test teams independently with little guidance
• Proficiency with programming languages and technologies commonly used in medical device development

Company Overview

Company H1B Sponsorship