Alcon · 1 day ago
Sr. Director, Regulatory Affairs, External Ocular Devices
Fort Worth, TX
Full-time
Onsite
Director/Executive
12+ years expAlcon is a company passionate about enhancing sight and helping people see brilliantly. The Sr. Director, Regulatory Affairs - External Ocular Devices will lead regulatory strategies for various product portfolios, ensuring compliance and collaboration with multiple teams to drive product approvals and maintain regulatory standards.
Health CareManufacturingMedical Device
Responsibilities
Strategically lead Regulatory Affairs team, ensuring compliance with regulatory requirements
Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports
Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, ensure rapid and timely approval of products and maintain approval throughout the product lifecycle
Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations
Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates to ensure timely submission and approvals
Oversee creative and innovative approaches to competitive claims development and labeling, advertising and promotional material review and approval for product portfolios, ensuring ethical conduct and compliance with applicable national and international laws, codes, and regulations
Proactively monitor and evaluate the US and OUS regulatory promotional environment by reviewing guidelines, enforcement letters, advisories from key international bodies and attending major industry meetings. Use this intelligence to inform promotional claim strategies
Provide US and Global Regulatory promotional perspective to business functions to ensure commercially viable labeling supporting business strategies
Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
Support products in either the medical device and/or pharmaceutical/OTC family of products, ensuring adherence to all relevant regulations
Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments and overall business outcomes
Oversee regulatory assessment and acquisition/integration strategy for all merger and acquisition (M&A) activities
Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
Contribute to the overall compliance of the organization and commit to continuous improvement in operations. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, 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
This role will support the External Ocular devices portfolio
Qualification
Required
Bachelor's Degree
The ability to fluently read, write, understand and communicate in English
12 Years of Relevant Experience
8 Years of Demonstrated Leadership
Travel: 20% Domestic and International
Work Location: Onsite – Fort Worth, TX (This role may be based at other Alcon locations, subject to business needs)
Relocation: Yes
Benefits
Health
Life
Retirement
Flexible time off for exempt associates
PTO for hourly associates
And much more!
Company
Alcon
Alcon specializes in developing and manufacturing innovative medicines and devices to serve the cycle of eye care.
10001+ employees
H1B Sponsorship
Alcon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (35)
2023 (12)
2022 (15)
2021 (45)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-12-15Acquired
2002-03-21IPO
Leadership Team
David Endicott
Chief Executive Officer
Tim Stonesifer
Chief Financial Officer
Recent News
Business Wire
2026-01-07
Medical Device Network
2026-01-07
Company data provided by crunchbase