Manager II, Regulatory Affairs Strategy

About the role

This role is part of Alcon’s Quality & Regulatory Affairs function. The function ensures Alcon’s products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality. The position supports 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 regulatory strategy execution with a focus on medical device consumables and accessories within the Surgical franchise, partnering cross-functionally to ensure alignment with evolving regulatory expectations.
• Develop and implement regulatory strategies for 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