Regulatory Affairs Specialist

Job title: Regulatory Affairs Strategy Associate

Location: Lake Forest, CA

Duration: Permanent

The Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for the regulatory strategy, ensuring local product registration and facilitating health registration approvals.

WHAT YOU’LL BRING : 

•          Bachelor’s Degree or Equivalent years of directly related experience (or high school +7 yrs; Assoc.+5 yrs; M.S.+3 yrs) 

•          7 Years of Relevant Experience 

•          The ability to fluently read, write, understand and communicate in

EXPECTATIONS / RESPONSIBILITIES:

•          A self-starter, assertive, who will be the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.

•          Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvals

•          Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations

•          Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training

•          Meet individual job requirements and contribute to the overall compliance of the organization