Manager II, Regulatory Affairs Strategy

About the role

Alcon is seeking a Manager II, Regulatory Affairs Strategy to support compliance activities for its Surgical portfolio of consumable and accessory medical devices. Based onsite in Houston (with other locations possible), you will act as a key regulatory resource, guiding country teams and ensuring timely product access worldwide.

Key responsibilities

• Conduct independent research and specialized tasks within the Regulatory Affairs Strategy team to meet project goals.
• Coordinate product submissions, renewals, and updates with plants, agents, and authorities.
• Oversee promotional material approval to ensure ethical conduct and regulatory compliance.
• Manage post‑approval commitments, lifecycle management, and rapid product approvals.
• Develop regulatory strategies for new product introductions and changes.
• Support medical device family products, adhering to relevant regulations and GxP standards.
• Collect and analyze regulations/standards, and engage with industry associations such as AdvaMed.

Required profile

• Strong scientific and technical product knowledge in surgical medical devices.
• Ability to provide regulatory guidance to country Regulatory Affairs associates.
• Experience collaborating cross‑functionally to align with evolving regulatory expectations.
• Commitment to continuous improvement and quality excellence.

Required skills

• Regulatory Affairs expertise
• Medical Device Regulations knowledge
• GxP compliance
• Product submission and lifecycle management