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Sr. Associate II, Regulatory Affairs Strategy at Alcon - ApplyBlast

Sr. Associate II, Regulatory Affairs Strategy

Alcon

5 months ago

2.7 on Glassdoor

Lake Forest, California

Onsite

Full Time

Senior

0 applicants

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About this role

A Sr. Associate II, Regulatory Affairs Strategy at Alcon supports regulatory compliance activities for Alcon's Surgical portfolio, focusing on Retina medical devices within the Surgical franchise.

Responsibilities

Develop regulatory strategies for new product introductions and changes
Coordinate product submissions, renewals, and updates
Develop product submission packages
Oversee promotional material approval
Manage post-approval commitments and lifecycle management

Skills

Qualifications

Bachelor’s Degree or Equivalent years of directly related experienceRegulatory Affairs experience in medical devices or healthcareKnowledge of global regulations (FDA, EU MDR, ISO 13485) and GxP/quality systemsExperience with global regulatory submissions (e.g., 510(k), CE Mark) and lifecycle managementFamiliarity with ophthalmic/retina or surgical medical devices

About Alcon

alcon.com

Headquarters

Cointrin, Geneva, Switzerland

Company Size

10001+ employees

Founded

1945

View Profile

Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.