Director, Regulatory Affairs Strategy

About the role

Alcon is seeking a senior leader to direct regulatory strategy for its Consumables & Accessories sub‑team within the Instrumentation GRA franchise. Based on the Lake Forest, California campus, the Director will guide product registration, ensure compliance with global regulations, and act as the primary liaison with health authorities.

Key responsibilities

• Lead a department within the Regulatory Affairs Strategy team, aligning strategies with corporate goals.
• Direct development and submission of product and process registrations, progress reports, supplements, amendments, and periodic experience reports.
• Provide strategic product direction and negotiate evidence requirements with regulatory agencies.
• Ensure rapid, timely approvals and maintain ongoing product compliance.
• Represent regulatory affairs to marketing, research project teams, and government agencies.

Required profile

• Extensive experience in regulatory affairs within the medical device or eye‑care industry.
• Proven leadership of cross‑functional teams and ability to influence senior stakeholders.
• Strong understanding of global GxP regulations and SOP adherence.
• Excellent communication and negotiation skills with health authorities.

Required skills

• Regulatory submission and product registration expertise.
• Knowledge of GxP compliance and documentation standards.
• Strategic planning and lifecycle management of medical products.

What we offer

• Opportunity to shape global regulatory strategy for a leading eye‑care company.
• Collaborative, inclusive culture with career growth potential.
• Competitive benefits and resources to support professional development.