Regulatory Operations Lead: Medical Devices Data

Alcon; Lake Forest (CA); On-site; USD 119,000 - 154,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

PTO for hourly associates

Job summary

Alcon seeks a Manager, Regulatory Operations (Management Path) to drive a controlled documentation system and coordinate global regulatory submission projects. You will guide teams in dossier preparation, submission publishing, licensing, and labeling across medical devices and pharmaceuticals.

The role is part of Alcon's Quality & Regulatory Affairs and requires leadership, project management, and regulatory expertise across US, EU, and Canada platforms.

Qualifications

• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience
• 3 Years of Demonstrated Leadership
• Location: Onsite- Fort Worth, TX, Lake Forest, CA
• Schedule: 1st Shift: Monday - Friday
• Travel Requirements: 0-10%
• Sponsorship & Relocation: Not Available

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

Skills

Regulatory operations

Project management

Cross-functional leadership

GxP/compliance

Education

Bachelor's degree or equivalent

Tools

FDA eSTAR

Health Canada REP

EU submission portals

Job description

Alcon seeks a Manager, Regulatory Operations (Management Path) to drive a controlled documentation system and coordinate global regulatory submission projects. You will guide teams in dossier preparation, submission publishing, licensing, and labeling across medical devices and pharmaceuticals.

The role is part of Alcon's Quality & Regulatory Affairs and requires leadership, project management, and regulatory expertise across US, EU, and Canada platforms.