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Regulatory Affairs Specialist

4 months ago

Fort Worth, United States Astrix Full time

Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.


Regulatory Affairs Specialist III


• Support the NBL Manager in Lifecycle Change Management projects.

• Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of regulatory support, review and approval of applications with the demonstrated ability to act independently to execute to foster and drive right first-time submissions.

• Driving on-time processing, submission, and oversight of Change Notification submissions to support Alcon business needs, to project completion.

• Collaborate with the MDR PMs, GRA strategists and cross- functional teams to support MDR Sub. Strategy and implementation timelines.

• Actively contribute to the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification reporting requirements

• Support the implementation of project related "regulatory excellence" activities as part of QS continuous improvement initiatives.


• Must have Medical Device experience. (Not Pharma)

• European MDR Experience

• Manufacturing background

• 4 Years of experience minimum (pure medical device)


This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you