Sr. Manager, Regulatory Affairs Strategy

Alcon•Fort Worth, TX

3d•$152,150 - $196,900•Onsite

About The Position

At Alcon, we’re passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates worldwide, we innovate fearlessly, champion progress, and act with speed to advance global eye health. At Alcon, you’ll be recognized for your contributions, supported by an inclusive culture, and empowered to grow your career like never before. Together, we go above and beyond to make a meaningful difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon’s Quality & Regulatory Affairs function—a critical organization responsible for ensuring our products meet global regulatory requirements and the highest standards of safety, quality, and performance. As a Senior Manager, Regulatory Affairs Strategy, you will lead regulatory compliance and strategy activities for Alcon’s Intraocular Device portfolio, including intraocular lenses (IOLs), implantable glaucoma devices and associated delivery systems. This onsite position is based in Fort Worth, Texas (other on-site locations available) and plays a key role in enabling compliant, timely access to innovative devices across global markets. Through your work, you will help strengthen regulatory excellence, support business objectives, and uphold Alcon’s commitment to quality, compliance, and patient safety. This role is on-site at any Alcon location and a typical day would include:

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience
5 Years of Demonstrated Leadership
Strong ability to develop and execute global regulatory strategies for complex medical devices
Deep understanding of implantable medical devices, preferably intraocular or ophthalmic technologies
Proven ability to influence cross-functional stakeholders and senior leadership
Excellent communication, negotiation, and regulatory writing skills
Ability to manage multiple priorities in a fast-paced, matrixed environment
Strong analytical thinking and problem-solving capabilities
Demonstrated commitment to quality, compliance, and patient safety

Responsibilities

Lead and oversee multiple projects within the Regulatory Affairs Strategy function, ensuring delivery of regulatory milestones through strong leadership and stakeholder alignment
Direct regulatory submission strategies, including registrations, supplements, renewals, and lifecycle updates across global markets
Act as the primary regulatory liaison, guiding teams on interactions with regulatory authorities and supporting negotiations to facilitate approvals
Provide strategic regulatory input for: New product development, Product and process changes, Lifecycle management activities
Ensure timely approvals and maintenance of approvals for marketed products
Oversee and ensure compliance of promotional materials, in accordance with applicable regulations and ethical standards
Interpret and apply global regulatory requirements to support business objectives and maintain compliance
Lead post-market activities, including inspections, regulatory inquiries, and maintenance of regulatory records
Drive regulatory intelligence activities, assessing evolving global requirements and translating them into actionable strategies
Collaborate with industry associations (e.g., ANSI, Advamed) to influence and stay aligned with regulatory developments
Commit to continuous improvement in operations and contribute to the organization's overall compliance
All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and completing all required training.
Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.