Senior Associate II – Regulatory Affairs Strategy

About the role

Alcon is seeking a Senior Associate II to join its Quality & Regulatory Affairs team. Based in Lake Forest, California, you will support regulatory compliance for Alcon's Surgical portfolio, with a focus on retina medical devices. The role involves ensuring timely product access across global markets while upholding the highest standards of quality and patient safety.

Key responsibilities

• Perform specialized regulatory research and contribute to project goals within the Regulatory Affairs Strategy team.
• Coordinate product submissions, renewals, and updates by liaising with manufacturing sites, agents, and regulatory authorities.
• Develop clear and complete submission packages to facilitate review and approval processes.
• Oversee promotional material approvals to ensure ethical conduct and regulatory compliance.
• Manage post‑approval commitments, lifecycle activities, and regulatory strategies for new product introductions and changes.
• Support medical device family products, adhering to relevant regulations and Good Practice (GxP) standards.
• Follow Standard Operating Procedures, maintain accurate documentation, and complete required training.
• Contribute to continuous improvement initiatives and overall compliance objectives.

Required profile

• Experience in regulatory affairs for medical devices, preferably within the surgical or retina segment.
• Strong scientific and technical product knowledge.
• Ability to work cross‑functionally and provide regulatory guidance to country teams.
• Commitment to quality, compliance, and patient safety.

Required skills

What we offer

• Opportunity to work in a global eye‑health leader.
• Inclusive culture that supports career growth.
• Access to cutting‑edge technologies and collaborative teams.