Global Regulatory Affairs Principal - Medical Devices

Alcon; Lake Forest (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Alcon is seeking a Global Regulatory Affairs Principal Specialist to join the Regulatory Affairs team at Fort Worth, TX, Johns Creek, GA or Lake Forest, CA. You will develop global regulatory strategy for new product development and direct submission work for US, EU and Canada markets.

The role involves negotiating with regulatory agencies and providing strategic direction across the product lifecycle. You will act as regulatory liaison to project teams, ensure regulatory compliance for trial

Qualifications

• Bachelor's degree or equivalent years of directly related experience.
• 5 Years of Relevant Experience.
• English fluency (read, write, understand)

Responsibilities

• Develops global regulatory strategy for new product development.
• Directs submission development of product registrations and reports.
• Interacts with regulatory agency personnel to expedite approvals.
• Serves as regulatory liaison on project teams throughout the product lifecycle.
• Ensures regulatory requirements for pre-clinical and clinical designs are met.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory liaison

Project management

Education

Bachelor's degree

Associate degree

MS

PhD

Job description

Alcon is seeking a Global Regulatory Affairs Principal Specialist to join the Regulatory Affairs team at Fort Worth, TX, Johns Creek, GA or Lake Forest, CA. You will develop global regulatory strategy for new product development and direct submission work for US, EU and Canada markets.

The role involves negotiating with regulatory agencies and providing strategic direction across the product lifecycle. You will act as regulatory liaison to project teams, ensure regulatory compliance for trial