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Senior Specialist, Product Security Lifecycle

Company: Alcon
Location: Lake Forest
Posted on: April 9, 2021

Job Description:

The Senior Specialist Product Security Lifecycle is responsible for managing and supporting the end-to-end Alcon Product Security Process to include maintaining policies, procedures, and standards within the Global R&D team. A key aspect of this role is to keep current the cybersecurity pre-market and post-market activities to support global medical devices regulations and compliances (e.g., FDA, MDR, GDPR, etc.). The Senior Specialist is knowledgeable in Alcon product security processes, medical device development, global regulations and cybersecurity concepts/technologies/frameworks.
We are looking for passionate individuals who enjoy working within a cross-functional Global R&D product development environment and has experience in the development of cybersecurity processes, standards, and relevant areas. This role supports the global product security objectives and initiatives as needed.
The responsibilities include but is not limited to:

  • Manage and maintain the Alcon Product Security Process (APSP) and related policies, procedure and standards, and other internal Alcon standard operating procedures (SOPs).
  • Ensure APSP processes and procedures are in compliance with global regulatory requirements, frameworks, FDA cybersecurity guidance, etc.
  • Manage and maintain the APSP content including process documentation, best practices, templates/forms and work instructions.
  • Support product security post-market processes (operations, incident management, change management processes, etc.).
  • Facilitate product security audits, third party assessment, and compliance initiatives and meet internal stakeholder requirements (HIPAA, UL 2900, and Quality, Regulatory, etc.).
  • Support global product registration filing needs and customer security documentation as needed.
  • Develop internal and external product security communication materials including training and awareness, product-specific materials, configuration/user guides, and other technical materials.
  • Collaborate with Alcon cross-functional team to support process improvements and automation as needed including reusable artifacts, tools implementation, security portals, etc.
  • Building capabilities, tools, where possible automate to drive improvements for Alcon product security process and practices.
    Basic Qualifications:
    • Bachelor's Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
    • Good communication skills
    • The ability to fluently read, write, understand, and communicate in English
    • 5 Years of Relevant Experience in cybersecurity processes, frameworks, regulations (FDA/MDR/HIPAA etc.)
      Preferred Qualifications:
      • Working knowledge in cybersecurity processes, frameworks, regulations (FDA/MDR/HIPAA) and product/software development process, agile processes, etc.
      • Demonstrated ability to communicate and collaborate effectively with Global teams.
      • Industry experience in a regulated environment, preferably Medical Device, MedTech, or health care experience.
      • Experience in the delivery and execution of product security processes, standards, best practices, and tools.
      • Knowledge and experience in leading complex products, services, and solutions especially security and related technologies.
      • Demonstrated ability to integrate cybersecurity frameworks and regulations into practices and procedures.
      • Thinks about creative ways to apply process management best practices to enable teams to operate more efficiently.

Keywords: Alcon, Lake Forest , Senior Specialist, Product Security Lifecycle, Other , Lake Forest, California

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