Senior Specialist, Product Security Lifecycle
Location: Lake Forest
Posted on: April 28, 2021
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
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
- Manage and maintain the APSP content including process
documentation, best practices, templates/forms and work
- 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
- 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.
- Bachelor's Degree or equivalent years of directly related
experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0
- 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.)
- 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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