Manager II, Regulatory Affairs Strategy

About the role

This role is part of Alcon’s Quality & Regulatory Affairs function—a critical organization responsible for ensuring our products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality. As a Manager II, Regulatory Affairs Strategy, you will support regulatory compliance activities for Alcon’s Surgical portfolio, including consumable and accessory medical devices.

Responsibilities

• Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals
• Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely submissions and approvals
• Oversee promotional material approval, ensuring ethical conduct and compliance with laws, codes, and regulations
• Ensure rapid and timely approval of products and their continued approval
• Manage post-approval commitments and lifecycle management
• Support new product introductions and changes, maintaining compliance to drive competitive advantage
• Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage
• Support products in the medical device family, ensuring adherence to relevant regulations
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training
• Support the collection and analysis of regulations/standards to ensure product compliance, and engage in activities of industry associations like Advanced Medical Technology Association as needed (AdvaMed)
• Commit to continuous improvement in operations and contribute to the organization's overall compliance

Requirements/Minimum 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.)
• The ability to fluently read, write, understand, and communicate in English
• 5 Years of Relevant Experience