Regulatory Operations Leader: Medical Device Submissions

Alcon; Lake Forest (CA); On-site; USD 152,000 - 197,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

PTO for hourly associates

Job summary

Alcon, a leader in eye care, seeks a Sr. Manager of Regulatory Operations to direct product and process submissions and align regulatory strategies worldwide.

This onsite role supports Fort Worth, TX and Lake Forest, CA, leading teams across dossier preparation, publishing, and labeling while ensuring timely approvals. The ideal candidate drives process improvements, demonstrates deep regulatory expertise across U.S., EU, and Canada, and mentors teams to optimize submission timelines within GxP

Qualifications

• Bachelor's Degree or equivalent or related experience.
• Fluent reading/writing/communication in English.
• 7 years of relevant regulatory experience.
• 5 years of demonstrated leadership.

Responsibilities

• Oversee multiple regulatory operations projects supporting medical device and/or pharmaceutical products.
• Lead teams for dossier preparation, Clinical Trial Disclosure, submission management, licensing, and labeling.
• Make key decisions impacting project performance and success.
• Apply project management, problem-solving, communication, and leadership skills.
• Adhere to GxP regulations by following SOPs and maintaining documentation and quality controls.
• Commit to continuous improvement and regulatory compliance.

Skills

Regulatory submissions

Project management

Leadership

GxP compliance

Education

Bachelor's Degree or Equivalent

Tools

FDA eSTAR

CECATS

Notified Body portals

Job description

Alcon, a leader in eye care, seeks a Sr. Manager of Regulatory Operations to direct product and process submissions and align regulatory strategies worldwide.

This onsite role supports Fort Worth, TX and Lake Forest, CA, leading teams across dossier preparation, publishing, and labeling while ensuring timely approvals. The ideal candidate drives process improvements, demonstrates deep regulatory expertise across U.S., EU, and Canada, and mentors teams to optimize submission timelines within GxP