Manager I, Regulatory Affairs Strategy

Responsibilities

• Support regulatory compliance and strategy for the Intraocular Device portfolio, including IOLs and implantable glaucoma devices.
• Develop regulatory strategies for new product introductions and lifecycle management to ensure timely global market access.
• Coordinate product submissions, renewals, and updates by liaising with manufacturing plants, agents, and regulatory authorities.
• Translate technical and clinical data into actionable regulatory strategies.
• Manage post-approval commitments and ensure adherence to relevant medical device regulations.
• Perform specialized research and analyze regulations/standards to maintain product compliance.
• Adhere to Good Practice (GDP) and GxP regulations, including following SOPs and maintaining accurate documentation.

Requirements

• Bachelor's Degree or equivalent years of directly related experience.
• 5 years of relevant experience in regulatory affairs or a related field.
• Fluency in reading, writing, and communicating in English.

Preferred Qualifications

• Experience within a matrixed organization.
• Strong regulatory writing skills.
• Ability to manage multiple priorities and complex timelines in a fast-paced environment.

Benefits

• Robust benefits package including health and life insurance.
• Retirement planning support.
• Flexible time off.
• Focused growth and professional development opportunities.

About the Company

Alcon is a global leader in eye care, dedicated to helping people see brilliantly. We develop and manufacture innovative devices and solutions across the full life cycle of eye care needs, from surgical equipment to consumer contact lens solutions. With over 25,000 associates worldwide, we foster an inclusive culture driven by a mission to improve sight and impact global eye health.