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

How to Thrive at Alcon

• Manage your own workload and schedule while hitting your set targets
• Build positive working relationships to achieve positive goals and business objectives

Alcon’s Total Rewards

• Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.

Alcon’s Commitment to Diversity and Inclusion

• Alcon is an Equal Opportunity Employer and participates in E-Verify.
• Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
• Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities.