Director, Regulatory Affairs Strategy

Alcon•Fort Worth, TX

2d•Onsite

About The Position

As a Director, Regulatory Affairs Strategy (Management Path) supporting Alcon’s Quality & Regulatory Affairs organization, this onsite role based at our Lake Forest, California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcon’s franchise portfolios. This position plays a critical role in ensuring products and processes meet global, regional, and local regulatory requirements. Primary responsibilities include providing strategic regulatory leadership across the product lifecycle, preparing and overseeing high‑quality regulatory submissions, and serving as the primary liaison with global health authorities to support timely product approvals. Additional responsibilities include leading and developing regulatory teams, collaborating cross‑functionally with R&D, Quality, Manufacturing, and Commercial partners, and driving lifecycle management strategies to ensure ongoing compliance and business continuity. The Director will be responsible for the Consoles sub-team within the Consoles, Consumables & Accessories, and Digital Health (CCD) organization of the Instrumentation GRA franchise. This role is part of Alcon’s Quality & Regulatory Affairs function, ensuring products meet the highest standards of quality, safety, and regulatory compliance. All associates are required to adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, completing required training, and supporting a culture of continuous improvement and regulatory excellence.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs.; Assoc.+14 yrs.; M.S.+7 yrs.; PhD+6 yrs.)
The ability to fluently read, write, understand, and communicate in English.
10 Years of Relevant Experience
6 Years of Demonstrated Leadership

Responsibilities

Lead a department within the Regulatory Affairs Strategy team, developing and implementing strategies for success and alignment with company goals
Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports
Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies
Ensure rapid and timely approval of products and their continued approval
Serve as the regulatory representative to marketing, research project teams, and government regulatory agencies
Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulations
Oversee regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvals
Oversee promotional material approval, ensuring ethical conduct and compliance with laws and regulations
Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance
Support products in the medical device family, ensuring adherence to relevant regulations
Collect and analyze regulations/standards to ensure product compliance and engage in activities of industry associations like Advanced Medical Technology Association (AdvaMed)
Support post-market inspection and explain approved information to customers, maintaining approval information in internal systems
Focus on talent development to enhance capabilities
Lead globally aligned regulatory strategies across development portfolios, marketed products, and line extensions
Manage post-approval commitments and lifecycle management
Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities
Coordinate regulatory activities for timely approvals and compliance
Lead and supervise regulatory liaisons, ensuring synergy across projects and driving competitive advantage through strategic decision-making