Senior Regulatory Ops Lead - Medical Devices

Alcon; Texas; Hybrid; USD 152,000 - 197,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Alcon is seeking a Sr. Manager, Regulatory Operations to direct product and process submissions, ensuring timely approvals and robust regulatory support globally.

You will lead cross-functional teams in dossier preparation, submission publishing, licensing, and labeling for medical devices and/or pharmaceuticals. The role emphasizes strategic oversight, leadership, and deep GxP knowledge, with a track record of optimizing submission timelines and improving regulatory processes.

Qualifications

• 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)
• Fluent in English (read, write, understand)
• 7+ years of relevant regulatory experience
• 5+ years of demonstrated leadership

Responsibilities

• Oversee multiple regulatory operations projects ensuring goals are met for medical devices and/or pharmaceutical products
• Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, licensing, and labeling
• Make key decisions impacting project performance and outcomes
• Apply project management, problem-solving, communication, leadership and regulatory knowledge
• Adhere to GxP and SOPs, maintain documentation and quality control
• Commit to continuous improvement and regulatory compliance

Skills

Regulatory submissions

GxP compliance

Global regulatory

FDA eSTAR

Health Canada REP

CE/Notified Body

CDRH CECATS

CFG/COE/FSC

Process improvement

Education

Bachelor’s Degree or equivalent

Job description

Alcon is seeking a Sr. Manager, Regulatory Operations to direct product and process submissions, ensuring timely approvals and robust regulatory support globally.

You will lead cross-functional teams in dossier preparation, submission publishing, licensing, and labeling for medical devices and/or pharmaceuticals. The role emphasizes strategic oversight, leadership, and deep GxP knowledge, with a track record of optimizing submission timelines and improving regulatory processes.