Manager II, Regulatory Affairs Strategy

Alcon Research • Houston, TX

21h • $105,000 - $175,000 • Onsite

About The Position

At Alcon, the Manager II, Regulatory Affairs Strategy will support regulatory compliance activities for Alcon’s Surgical portfolio, including consumable and accessory medical devices. This onsite position is based in Houston, Texas (other on-site locations available) and plays an important role in enabling compliant and timely product access across the global marketplace. The role involves developing strong scientific and technical product knowledge and serving as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. The Manager II will 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. Through this work, the individual will help strengthen regulatory excellence, support business objectives, and uphold Alcon’s commitment to quality, compliance, and patient safety. The role is part of Alcon’s Quality & Regulatory Affairs function, which is responsible for ensuring products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +20 yrs.; Assoc.+16 yrs.; M.S.+9 yrs.; PhD+8 yrs.)
• The ability to fluently read, write, understand, and communicate in English

Nice To Haves

• 2 Years of Relevant Experience

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
• 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
• Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and completing all required training.
• Meet individual job requirements and contributing to the overall compliance of the organization.

Benefits

• robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!
• compensation (fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population)
• life and disability insurance
• savings for retirement
• good health and well-being support
• support for associates and their families during times of illness

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees