Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices)

Alcon Research•Fort Worth, TX

6d•Onsite

About The Position

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Manager, Regulatory Operations (Management Path) is primarily responsible for directing product/process submissions, ensuring timely approvals, and maintaining high-quality regulatory support. You will lead negotiations to align on optimized regulatory strategies and manage global strategies to enhance product value.

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

Responsibilities

Oversee multiple regulatory operations projects, ensuring goals are met through effective management and oversight in support of medical device and/or pharmaceutical products
Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling, ensuring timely and accurate submission of regulatory documents
Make key decisions impacting project performance and success
Apply project management, advanced problem-solving, effective communication, leadership, and industry-specific knowledge
Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and ensuring quality control
Commit to continuous improvement and compliance with regulatory requirements
Demonstrate deep expertise in the regulatory submission lifecycle and associated processes for Class I, Class II, and Class III medical devices across the United States, European Union, and Canada
Possess comprehensive knowledge of key regulatory submission platforms and portals, including the U.S. Food and Drug Administration (FDA) electronic Submission Template and Resource (eSTAR), Health Canada Regulatory Enrolment Process (REP), and European Union Notified Body submission portals.
Experienced in managing export certification activities through the Center for Devices and Radiological Health (CDRH) Export Certification Application and Tracking System (CECATS), including Certificates to Foreign Government (CFG), Certificates of Exportability (COE), and European Union Free Sale Certificates (FSC).
Lead the optimization and standardization of apostille, notarization, legalization, and country-specific documentation processes to support international regulatory submissions, accelerate approval timelines, and improve operational efficiency.
Serve as a subject matter expert on global registration and submission pathways, providing strategic guidance for regulatory submissions and market access activities across the U.S., EU, Canada, and international markets.
Identify and implement process improvements that reduce submission cycle times, enhance compliance, and improve the quality and consistency of regulatory documentation.