Sr. Associate II, Regulatory Affairs Strategy

Alcon Research•Lake Forest, CA

4d•$102,850 - $133,100•Onsite

About The Position

This role is part of Alcon's Quality & Regulatory Affairs function, a critical organization responsible for ensuring our products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality as we help people see brilliantly. The Sr. Associate II, Regulatory Affairs Strategy is primarily responsible for supporting regulatory compliance activities for Alcon's Surgical portfolio. This onsite position is based in Lake Forest, California and plays an important role in enabling compliant and timely product access across the global marketplace. In this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. You will support regulatory strategy execution with a focus on Retina medical devices within the Surgical franchise, partnering cross-functionally to ensure alignment with evolving regulatory expectations. Through your work, you will help strengthen regulatory excellence, support business objectives, and uphold Alcon’s commitment to quality, compliance, and patient safety.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
The ability to fluently read, write, understand and communicate in English
2 Years of Relevant Experience

Nice To Haves

Regulatory Affairs experience in medical devices or healthcare.
Regulatory Affairs Certified (RAC).
Knowledge of global regulations (FDA, EU MDR, ISO 13485) and GxP/quality systems.
Experience with global regulatory submissions (e.g., US PMA, US 510(k), EU CE Mark) and medical device lifecycle management.
Ability to develop and execute regulatory strategies for new products and changes.
Familiarity with ophthalmic/retina or surgical medical devices.
Strong technical writing and submission documentation skills.
Experience collaborating cross-functionally and with regulatory authorities.
Strong analytical, research, and problem-solving abilities.
Excellent communication, organization, and attention to detail.

Responsibilities

Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals.
Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure rapid and timely submissions and approvals.
Develop product submission packages that are clear, concise, and complete to facilitate reviews/approvals.
Oversee promotional material approval, ensuring ethical conduct and compliance with laws, codes, and regulations.
Manage post-approval commitments and lifecycle management.
Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage.
Support products in the medical device family, ensuring adherence to relevant regulations.
Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training.
Commit to continuous improvement in operations and contribute to the organization's overall compliance.
All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and completing all required training.
Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.