Sr. Associate II, Regulatory Affairs Strategy

Responsibilities

• Support regulatory compliance activities for Alcon's Surgical portfolio, with a specific focus on Retina medical devices.
• Coordinate product submissions, renewals, and updates by liaising with manufacturing plants, agents, and regulatory authorities.
• Develop clear and complete product submission packages to facilitate efficient reviews and approvals.
• Oversee the approval of promotional materials to ensure ethical conduct and compliance with all applicable laws and regulations.
• Manage post-approval commitments and product lifecycle management.
• Provide regulatory strategies for new product introductions and changes to maintain compliance and competitive advantage.
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs) and maintaining accurate documentation.

Requirements

• Bachelor's Degree or equivalent years of directly related experience.
• 2 years of relevant professional experience.
• Fluency in reading, writing, and communicating in English.
• Ability to work onsite in Lake Forest, California.

Preferred Qualifications

• Regulatory Affairs experience specifically within the medical device or healthcare industry.
• Knowledge of global regulations including FDA, EU MDR, and ISO 13485.
• Experience with global regulatory submissions such as 510(k) and CE Mark.
• Familiarity with ophthalmic, retina, or surgical medical devices.
• Strong technical writing and submission documentation skills.
• Proven ability to collaborate cross-functionally and with regulatory authorities.

Benefits

• Robust benefits package including health and life insurance.
• Retirement savings plans.
• Flexible time off for exempt associates and PTO for hourly associates.
• Focused growth and professional development opportunities.

About the Company

Alcon is a global leader in eye care, dedicated to helping people see brilliantly. With more than 25,000 associates worldwide, we innovate to advance global eye health through the development and manufacture of innovative surgical and consumer products.